Benicar Side Effects & Pending Lawsuits

NOTICE: The Drug Law Center is no longer accepting these type of cases. This page is strictly for informational purposes. We appreciate your cooperation and understanding by not contacting our office on these cases. We are actively investigating and prosecuting cases involving Valsartan cancers. For information on Valsartan lawsuits, look here.

The Benicar injury case attorneys at the Drug Law Center are now reviewing and accepting cases involving patients who of suffered harm after taking the antihypertensive medication.

Introduction

Benicar (olmesartan medoxomil) is a brand-name prescription medication that narrows blood vessels, lowers blood pressure and improves the flow of blood throughout the body. The angiotensin II receptor antagonist medication is also prescribed for the treatment of hypertension (high blood pressure) in adults and children who are six years and older. However, drugs that contain olmesartan medoxomil, including Benicar, as a treatment for hypertension can also produce serious side effects. The medication has been linked to serious side effects, severe health problems and adverse reactions including sprue-like enteropathy. The FDA has issued warnings that the medication might cause intestinal issues. Many injured patients have filed Benicar lawsuits against the drug maker Daiichi Sankyo for producing, marketing and selling the defective medicine.

The History of Benicar

The Japanese pharmaceutical giant Daiichi Sankyo developed the generic version of the angiotensin II receptor antagonist Benicar, olmesartan medoxomil, in 1995. Since the company received approval for Benicar in 2002 by the FDA, the hypersensitive medication as generated billions of dollars in annual global sales. The lucrative Benicar patent held by the drug maker expired in 2016.

In 2013, the US FDA (Food and Drug Administration) issued a warning to consumers that Benicar (olmesartan medoxomil) can produce severe health problems including substantial weight loss and chronic diarrhea. Many in the health care industry have criticized the medication because it can produce a severe gastrointestinal side effect. Even though the drug produces dangerous side effects and no other medicines in the same class produce sprue-like enteropathy like Benicar, the pharmaceutical company continues to promote medication as though it is safe.

Who Should Avoid Taking Benicar?

While Benicar can provide health benefits to patients including lowering blood pressure, some people should avoid taking the medication due to its contraindications. Before taking Benicar (olmesartan), it is important for patients to discuss potential health risks and side effects if they have any of the following:

• Low bloodstream sodium levels (hyponatremia)
• High bloodstream potassium levels (hypercalcemia)
• Type II diabetes myelitis
• Renal impairment
• Renal artery stenosis
• Diarrhea caused by intestinal malabsorption
• Decreased blood volume
• Pregnancy
• Severe congestive heart failure
• Giant hives

Additionally, an individual that is allergic to olmesartan ARB-angiotensin II receptor antagonist should avoid taking the medication.

Benicar Side Effects

Benicar (olmesartan), like most prescription medications and over-the-counter drugs, can produce mild to severe side effects and adverse reactions. The most common minor Benicar side effects include:

• Nausea
• Diarrhea
• Dizziness
• Lightheadedness
• Skin rash
• Itching
• Headaches
• Overall weakness
• Stomach, muscle, or joint pain
• Flu like symptoms
• Sinus infection
• Gross hematuria (blood in the urine)

Potentially severe Benicar side effects include:

• Rhabdomyolysis (breakdown of muscle tissue)
• Hypercalcemia (elevated bloodstream potassium levels)
• Vertigo (spinning or whirling sensation)
• Abnormally low blood pressure
• Throat irritation
• Bladder pain
• Stiffness, swelling or painful joints
• Irregular, pounding or fast pulse or heartbeat
• Difficulty urinating
• Painful or burning urination
• Acute renal failure
• Coughing
• Indigestion
• Intense abdominal pain
• Chest pain
• Difficulty in swallowing or breathing
• Renal failure
• Upper respiratory tract infections
• Bronchitis
• Vomiting
• Puffy face and swollen hands, arms, feet or legs caused by water retention
• High bloodstream uric acid levels

 Benicar and the Food and Drug Administration

• July 2013 – The U. S. FDA issued a warning to consumers that drugs containing olmesartan medoxomil to treat blood pressure have the potential of causing serious intestinal problems including sprue-like enteropathy. These medical products are marketed as Benicar, Benicar HCT, Tribenzor, Azor, and their respective generic versions. The Food and Drug Administration mandated that the drug makers of these products update approve label changes to keep the public informed.The Safety Announcement published in July 2013 defined olmesartan medoxomil as an ARB (angiotensin II receptor blocker) that received approval by the FDA to treat high blood pressure. The product can be used alone or concomitantly with other anti-hypersensitive agents. Federal agency officials stated that the drug was approved to lower blood pressure while reducing the potential risk of non-fatal and fatal cardiovascular events including heart attacks and strokes. The federal agency revealed that there were no other ARB medications that produce sprue-like enteropathy other than olmesartan. The FDA released prescription data revealing that in 2012, more than 10.5 million prescriptions had been written by doctors to nearly two million patients who were dispensed olmesartan-containing drugs in the United States.
• June 2014 – The Food and Drug Administration published its findings in a Safety Review revealing that no clear evidence of an increased potential risk of cardiovascular events was found at the conclusion of the study. The study involved diabetic patients taking olmesartan, a blood pressure medication.The safety review was a part of a clinical trial that examined the outcome of type II diabetic patients taking olmesartan medoxomil products to see if the medication delays kidney damage. Clinical trial researchers identified an unexpected result involving the olmesartan medication taking group but there was an increased risk of cardiovascular death when compared to the group taking sugar pills (placebos). However, the findings also revealed a lower potential risk of non-fatal heart attacks compared to those taking the blood pressure reducing medication.
• March 2012 – The Food and Drug Administration issued a fetotoxicity warning involving mothers taking Benicar (olmesartan) to treat hypertension and lower blood pressure. The Benicar Black box warning label indicated that “when pregnancy is detected, discontinue Benicar soon as possible. Drugs that act directly on the renin-angiotensin II system can cause injury and death to the developing fetus.”
  Additional warnings and precautions issued by the FDA for pregnant women taking Benicar include:
  • “Avoid fetal (in utero exposure.
  • Children [less than 1] year of age must not receive Benicar for hypertension.
  • Observe for signs and symptoms of hypotension in volume or salt-depleted patients with treatment initiation.
  • Monitor for worsening renal function in patients with renal impairment.”

Benicar Recall

To date, the FDA nor Daiichi Sankyo, the maker of low blood pressure treatment medication, has yet to recall Benicar due to its link with causing sprue-like enteropathy. However, the Food and Drug Administration has recommended that the drug manufacturer update label changes to inform the drug’s consumers of the serious potential side effects the drug can cause including intestinal problems.

Benicar Lawsuits

In 2015, Daiichi Sankyo, the pharmaceutical company that developed, manufacturers and markets the prescription blood lowering medication reached a $39 million Benicar settlement with the United States federal government. The lawsuit plaintiffs had alleged the drug maker paid kickbacks to doctors in exchange for prescribing its medications including Tribenzor, Azor, Benicar HCT, and Benicar.

• Drug Makers Facing Another Benicar Lawsuit Filed by an Ohio PlaintiffJanuary 2015 – An Ohio man has filed a Benicar lawsuit in an Ohio Federal courthouse against Daiichi Sankyo, Inc. and Forest Laboratories Inc. The plaintiff is seeking financial recompense from the drug makers after he developed colonic issues and severe intestinal problems involving sprue-like enteropathy, microscopic colitis, intestinal malabsorption, colitis, and collagenous colitis. The plaintiff’s attorneys are claiming that their client suffered Benicar side effects after taking the medication including dehydration, malnutrition, vomiting, nausea, acute renal failure, rapid weight loss, and chronic diarrhea. As a result of ongoing suffering from the side effects, the plaintiff also developed severe weakness and anemia requiring hospitalization on numerous occasions. His doctors continue to monitor’s health problems.
• New York Woman Files Benicar Lawsuit against Drug Makers after Suffering Painful Side EffectsMarch 2015 – The makers of Benicar are in a legal battle with a New York woman who claims she suffered injuries caused by the blood pressure medication. The plaintiff is alleging that Benicar caused her to develop sprue-like enteropathy and other serious intestinal harm.Lawsuit documents reveal that her doctors prescribed Benicar as a treatment for arrived blood pressure. Even though the drug worked as directed, the plaintiff was simultaneously suffering painful side effects and embarrassment from her intestinal difficulties. Soon afterward, the plaintiff began experiencing serious Benicar side effects including weight loss, dehydration, and diarrhea.The New York plaintiff claims that Daiichi Sankyo, Inc. and Forest Laboratories Inc., makers of Benicar, failed to provide adequate warning in their Black box warning label. Her attorneys have built a financial compensation claim against the drug makers stating that they were responsible for warning her, her doctors and other patients who were taking the medication. The lawsuit is based on numerous factors including the companies’ failures that involved false advertising, negligence, product misrepresentation and concealing safety information.
• Benicar Wrongful Death Lawsuit Filed by New Jersey Widow against Two Major Pharmaceutical Companies
  December 2014 – A New Jersey widow has filed a Benicar lawsuit alleging that her husband died after taking the popular hypertension treatment medication. The woman’s case joins seven other lawsuits that have been consolidated in a New Jersey federal court. Lawsuit documents reveal that the plaintiff’s husband had been prescribed Benicar by his doctors as an effective solution for treating his hypertension and managing elevated blood pressure levels. However, the wrongful death lawsuit makes claims that before the husband passed away he had developed severe side effects from the medication including a gastrointestinal disease and sprue-like enteropathy that causes uncontrollable diarrhea. The widow has made claims that her deceased husband needed to be hospitalized because he was suffering greatly from the side effects including uncontrollable diarrhea that resulted in sustaining severe gastrointestinal tract damage and excessive weight loss.

This is hardly the first time that Daiichi Sankyo, Inc. and Forest Laboratories Inc., the makers of the blood lowering medication, have faced injured patients and surviving family members. The number of lawsuits filed against the two pharmaceutical giants has created the need to consolidate many existing cases into a Benicar class action lawsuit.

What to Do If You Been Injured

The Benicar injury case attorneys at the Drug Law Center are now in discussion with patients who have suffered chronic diarrhea, vomiting, excessive weight loss, and other serious gastrointestinal side effects after they took Benicar, olmesartan or other brands of the blood pressure medication. Our attorneys are investigating, evaluating, and determining which victims are eligible to file a Benicar lawsuit against the drug maker.

If you have suffered an injury, or lost a loved one, due to the side effects and adverse reactions caused by taking Benicar, contact us today so we can begin the process of obtaining your financial compensation award from the drug maker. To minimize the financial burden for you and your family during the litigation process, we are currently postponing payment of our legal services until after we have successfully resolved your case. This could happen through a jury trial award or negotiated out-of-court settlement.

We provide free initial consultations to discuss the merits of your case. All information you share with our law offices remains confidential.

Sources:

http://www.mayoclinic.org/drugs-supplements/olmesartan-oral-route/description/drg-20065169

http://bmjopen.bmj.com/content/5/11/e010077

http://www.cleveland.com/healthfit/index.ssf/2010/06/uh_cardiologists_research_warn.html

Benicar Lawsuits – Gastrointestinal Side Effects & FDA Warning

Benicar Overview

Benicar (olmesartan medoxomil) was approved by the Food and Drug Administration in 2002 to treat high blood pressure (hypertension). It is a member of the “angiotensin receptor blockers” (ARB) class of anti-hypertensive medications.

Benicar is manufactured and marketed in the US by the Daiichi Sankyo, the second-largest pharmaceutical company in Japan. Daiichi Sankyo sells pharmaceutical, medical, and agricultural products in 50 countries and reports about $12 billion in annual revenue. Between 2010 and 2013, Benicar was selling at a yearly rate of about 11 million U.S. prescriptions and brought $3 billion per year in global revenue.

The active ingredient in Benicar (olmesartan) is also one ingredient in combination high-blood pressure medications such as Benicar HCT (olmesartan with hydrochlorothiazide, a diuretic), Azor (olmesartan with amlodipine, a calcium channel blocker), and Tribenzor (olmesartan with hydrochlorothiazide and amlodipine).

Unlike other members of the ARB class of blood pressure medications, Benicar has been shown to cause a serious gastrointestinal side effect known as “sprue-like enteropathy” which can cause severe, chronic diarrhea and significant weight loss and is similar to symptoms of celiac disease. Multiple lawsuits have been filed against Daiichi Sankyo for serious injury caused by Benicar and more are expected to follow.

What is Benicar?

Benicar is an inhibitor of the angiotensin-II receptor, also known as an angiotensin receptor blocker (ARB) or a “sartan” because of the generic name olmesartan. The ARB class of anti-hypertensives work by blocking the activity of angiotensin-II in the cardiovascular system.

Angiotensin-II is a product of the liver which is intended to regulate the blood pressure system. When the protein is produced by the liver, it has a vasoconstrictive effect that tightens the blood vessels and raises blood pressure. Increased blood pressure makes the heart work harder to pump blood through the body and can also damage other organs such as the kidneys. Blocking angiotensin-II helps to lower the blood pressure by stopping vasoconstriction. This helps the blood flow more freely through the vessels and decreases the work the heart must do to supply the body with blood and oxygen.

Benicar FDA Warnings

Benicar was shown to cause severe gastrointestinal illness in some patients who took the medication in a research connection discovered by the Mayo Clinic in 2012. The Mayo Clinic notified the FDA about a high occurrence of “sprue-like enteropathy” that had symptoms similar to Celiac disease with side effects such as severe and chronic diarrhea, lack of nutrient absorption and extreme weight loss.

All of the observed patients had tested negative for Celiac disease, but all had taken Benicar. Most patients who were identified as Benicar related illnesses improved after discontinuing the medication, but some did not. The rate of non-Celiac or unclassified sprue occurrence may be as high as 30 percent. Following the Mayo Clinic’s report, the FDA added a warning to prescribing information of Benicar in July of 2013.

Benicar also has a black-box warning regarding the risk of birth defects in women who are pregnant while taking the medication. Benicar and other related medications containing olmesartan are the only member of the ARB class of medications that have caused the GI side effects, many patients have sued the manufacturer, Daiichi Sankyo for injuries, hospitalization and permanent damage caused by Benicar.

Benicar Side Effects

Benicar and medications containing olmesartan have a number of side effects. Like most medications, many of these side effects are mild to moderate but may have a negative impact on the patient’s quality of life. In other cases, however side effects are more severe and may be life-threatening.

Common side effects of Benicar include:

• Rash
• Hair loss
• Arthritis
• Nausea and vomiting
• Irregular heartbeat
• Chest pain
• Angioedema (swelling of the skin)
• Liver and kidney impairment

If side effects worsen or become bothersome, they may indicate a more serious medical problem and should be reported to a physician.

Benicar Severe GI Side Effects

Benicar may also cause a much more severe adverse event affecting the gastrointestinal system in a condition known as “sprue-like enteropathy”. In July of 2013, the FDA began requiring a warning about the gastrointestinal side effects of Benicar or sprue-like enteropathy.

Sprue-like enteropathy causes severe symptoms that are similar to Celiac disease, but the patient does not have and will test negative for Celiac disease. Dietary changes normally recommended for Celiac patients will not help those with Benicar-related gastrointestinal illness.

GI symptoms caused by Benicar include:

• Severe abdominal pain
• Severe and chronic diarrhea
• Nutrient malabsorption
• Significant weight loss

Doctors will often test for Celiac disease when a patient reports these symptoms. Unfortunately, in some cases even if Benicar is discontinued, the patient will continue to suffer from the gastrointestinal illness, and they will not respond to traditional Celiac regimens.

Some patients have suffered with the illness for multiple years, seen multiple physicians and may have been hospitalized for the illness. In addition, some patients may have permanent injury to the gastrointestinal system with a condition known as “villous atrophy” which results in a permanent lack of ability of the GI system to absorb nutrients.

Some cases of villous atrophy may be so severe that the small intestine allows larger undigested food particles to pass into the blood stream. These particles can cause a severe immune reaction, resulting in body-wide inflammation and a number of food sensitivities.

Benicar Mayo Clinic Report

In 2012, the Mayo Clinic released a report and notified the FDA about the occurrence of “sprue-like enteropathy” in multiple patients. These patients had symptoms that were similar to Celiac disease but tested negative for the disorder. In addition, dietary changes normally recommended for Celiac patients, such as eliminating all gluten from the diet, did not resolve the illness. All of the identified patients had been taking Benicar.

After discontinuation of the medication, some of the patients saw improvement in their symptoms but others may have suffered permanent damage. In July of 2013, The FDA required that a warning be added to the prescribing information on Benicar regarding the risk of gastrointestinal effects. Benicar, and other products containing olmesartan, is the only member of the ARB class that has caused this side effect.

Benicar Black Box Warning

The top of the prescribing information for Benicar includes a black-box warning. A black-box warning is the most severe warning that a medication can have and is placed inside a box with a thick black border so that it is readily seen by healthcare professionals who prescribe the medication.

Benicar’s black-box warning indicates a high risk of the development of birth defects and the possibility of fetal death in pregnant women who take Benicar. Benicar or other products containing olmesartan should not be taken by women who are pregnant or intend to become pregnant.

Benicar Legal Trouble

The maker of Benicar has landed in legal trouble multiple times. The company received warnings from the FDA in 2006 and 2013 due to its claims about Benicar and the risks associated with use of the drug. There have also been concerns about Benicar research trials which were run for only three months, when most people require blood pressure medications for much longer. It is believed that had the trials been in line with real use-experience, side effects of the drug might have been more evident prior to the drug’s release.

In addition, some independent reviews of adverse event data showed that Daiichi Sankyo should have been aware of the increased GI complaint rate but Daiichi failed to include this information in marketing material.

Benicar Lawsuit Information

A number of patients who were injured after taking Benicar sued the manufacturer, Daiichi Sankyo Inc. Some patients were required to undergo years of medical treatments with extreme pain and physical debility caused by their drug injuries including gastrointestinal complaints and other health conditions such as nutrient malabsorption and weight loss.

Some patients required hospitalization to treat drug injury complications and may have been left with permanent injury or disability such as the failure of the digestive system or need for a permanent feeding tube

Daiichi Sankyo is reported to have spent approximately $1 billion in aggressive promotions claiming Benicar was superior to other ARBs with an increased safety and efficacy profile which was not proven. Daiichi Sankyo was twice warned by the FDA for making false or misleading claims about the medication indicating that claims were unsubstantiated, and risks were not included in marketing materials.

Multiple lawsuits were filed against Daiichi Sankyo for aggressive promotion, deceptive advertising, and failure to warn the medical community and patients about the increased risk of side effects and permanent injury. In 2017, Daiichi Sankyo and co-marketer Forest Laboratories announced they would be spending up to $300 million to settle lawsuit claims against Benicar, Benicar HCT, Azor and Tribenzor for sprue-like enteropathy and other severe GI complaints.  This settlement agreement was reported to cover at least 2,300 cases already filed and a number that may have been expected.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 

Drugs That Should Not Be Taken with Benicar

Posted on July 22, 2016

If you’re one of the approximately 67 million Americans that suffers from hypertension (high blood pressure) you may have been prescribed Benicar for your condition. Benicar is the brand name for olmesartan medoxomil which is manufactured by Japanese pharmaceutical giant, the Daiichi Sankyo Company. Benicar was approved by the U.S. Food and Drug Administration (FDA) in 2002 and has since become the subject of many lawsuits due to side effects associated with it. In addition to side effects like kidney failure and severe diarrhea, serious drug interactions have caused many people prescribed the medication to become ill. If you are taking Benicar it is strongly advised that you do not take any of the following medications or supplements:

• aspirin
• atorvastatin
• Bystolic (nebivolol) amlodipine
• Crestor (rosuvastatin)
• Cymbalta (duloxetine)
• Fish Oil (omega-3 polyunsaturated fatty acids)
• gabapentin
• levithyroxine
• Lipitor (atorvastatin)
• Lyrica (pregabalin)
• Metformin
• Metoprolol
• Nexium (esomeprazole)
• Prilosec, Losec, (omeprazole)
• Zocor (simvastatin)
• Synthroid (levothyroxine)
• Ultram, ConZip, Ryzolt (tramadol)
• Vitamin D3 (cholecalciferol)

If your doctor prescribes Benicar for you, it is important to tell them about any other medications or supplements you are taking. If you have been treated with Benicar and have experienced any side effects or drug or supplement adverse interactions, you may be entitled to compensation for medical bills, pain and suffering, lost wages, and more. However, getting a fair settlement from a huge corporation like the Daiichi Sankyo Company is no slam dunk. Pharmaceutical corporations employ armies of lawyers to minimize the payouts they are forced to make. To get a settlement worthy of your injuries, it is vital that you have a seasoned legal team to represent you. The Benicar attorneys at the law offices of Farah & Farah have been defending the rights of injury victims since 1979 and will put their litigating skill behind your claim. Call 1(800) 533-3555 for a free consultation.

Did You Take Benicar For High Blood Pressure?

Around 70 million adults in America have high blood pressure. That equates to one in three adults, and about half of these people use medication to control their hypertension. High blood pressure increases the risk of heart attack, stroke, chronic heart failure, and kidney disease.

Benicar (olmesartan medoxomil) is a common prescription drug used to control hypertension. While the drug does lower the risk of cardiovascular problems, this may come at a higher cost than anyone anticipated.

Benicar has been linked to severe gastrointestinal problems. The conditions caused by Benicar include sprue-like enteropathy and villious atrophy, which destroys the finger-like villi in the intestinal that absorb nutrients from food. Symptoms can include chronic diarrhea, malnutrition and weight loss.

The side effects of Benicar are very similar to Celiac disease. Because of this, doctors can misdiagnose these side effects, which can have serious long-term health effects. A Food and Drug Administration report based on data from the Mayo Clinic called Benicar’s side effects “life-threatening.”

Signs and symptoms

While symptoms improved after stopping use of the drug, damage to the gastrointestinal system can be permanent. In addition to these severe effects, Benicar has been associated with:

• Abdominal pain
• Nausea
• Vomiting
• Kidney damage
• Liver damage
• Chest pain
• Arthritis
• Hair loss
• Angioedema (swelling of the skin)

Damage caused by the medication is not only serious in the short term, resulting in severe weight loss and malnutrition, but the long-term effects can accrue medical bills staggeringly quickly. When the villi of the intestine are damaged, it can become impossible for you to absorb necessary nutrients from food. In extreme cases, malnutrition can result in permanent organ damage and death.

Furthermore, Benicar may lead to fetal toxicity, making the drug especially dangerous to pregnant women. If the drug passes through the placental membrane, it could lead to developmental defects later. It could also potentially cause the death of your child.

If you are taking Benicar, we advise you talk to your doctor immediately. Other medications with less severe side effects are available. If you have experienced any of the side effects listed above from prescription Benicar and have found it necessary to seek medical attention, Crandall & Pera Law is here to help you. Please contact our firm to schedule a consultation at one of our multiple office locations throughout Ohio and Kentucky.

Benicar HCT | Healthgrades | (olmesartan medoxomil-hydrochlorothiazide tablet, film coated)

Brand Name: Benicar HCT

Generic Name: OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET, FILM COATED

Data Current As Of: 2018-10-05

BENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure. BENICAR HCT is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)].

Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with BENICAR HCT.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

BENICAR HCT may be used alone, or in combination with other antihypertensive drugs.

patient counseling information

Pregnancy: Advise female patients of childbearing age about the consequences of exposure to BENICAR HCT during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [see Use in Specific Populations (8.1)].

Symptomatic hypotension and syncope: Advise patients that lightheadedness can occur, especially during the first days of therapy, and to report this symptom to a healthcare provider. Inform patients that dehydration from inadequate fluid intake, excessive perspiration, vomiting, or diarrhea may lead to an excessive fall in blood pressure. If syncope occurs advise patients, to contact their healthcare provider.

Potassium Supplements: Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider.

Acute myopia and secondary angle-closure glaucoma: Advise patients to discontinue BENICAR HCT and seek immediate medical attention if they experience symptoms of acute myopia or secondary angle-closure glaucoma [see Warnings and Precautions (5.6)].

Manufactured for Daiichi Sankyo, Inc., Parsippany, New Jersey 07054

Copyright © Daiichi Sankyo, Inc. 2016. All rights reserved.

olmesartan medoxomil-hydrochlorothiazide

• Olmesartan Medoxmil and Hydrochlorothiazide (tablet, film coated)
• OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (tablet)

Olmesartan medoxomil-based treatments effectively lower blood pressure

Hypertension

Results of two studies presented at the American Society of Hypertension An-nual Scientific Meeting found that olmesartan medoxomil (Benicar) and olmesartan medoxomil/hydrochlorothiazide (Benicar HCT) can effectively treat patients with Stage 1 and Stage 2 hypertension to achieve blood pressure goals.

The Benicar Efficacy in Systolic Hypertension Trial (BEST) was a 16-week, prospective, open-label, multicenter study that included 176 patients with Stage 2 hypertension (mean blood pressure 171/95 mm Hg). After a 3- to 4-week, pla-cebo run-in period, the patients (mean age 60 years) were given a 20-mg dose of olmesartan medoxomil once daily. Doses were up-titrated at 3-week intervals if blood pressure remained at 120/80 mm Hg or higher, to 40 mg olmesartan medoxomil daily, then 40/12.5 mg daily of olmesartan medoxomil/hydrochlorothiazide, and then to 40/25 mg daily of olmesartan medoxomil/hydrochlorothiazide. The primary end point was mean change in baseline systolic blood pressure at 12 weeks. The secondary end points assessed blood pressure changes from baseline after each titration period as well as the number of patients who achieved the blood pressure goal of 140/90 mm Hg or lower or normalization of blood pressure to below 120/80 mm Hg. Results showed that the 40/25-mg dose of olmesartan medoxomil/hydrochlorothiazide helped 70% of patients with a mean blood pressure of 171/95 mm Hg to reach the goal of below 140/90 mm Hg. This treatment lowered systolic blood pressure by an average of approximately 35 mm Hg.

Results of another study presented at the meeting, Treatment of Stage 1 and Stage 2 Hypertension Utilizing an Olmesartan Medoxomil-based Treatment Algorithm, also demonstrated the efficacy of olmesartan medoxomil/hydrochlorothiazide,

as well as olmesartan medoxomil. This study, a 24-week, multicenter, open-label trial, included 79 patients with Stage 1 hypertension and 100 patients with Stage 2 hypertension. Patients were started on olmesartan medoxomil, 20 mg daily, after a placebo run-in phase of up to 4

weeks. If the goal of 130/85 mm Hg or lower was not achieved, the dose was increased at 4-week intervals according to the study algorithm, using the same doses as in the BEST study for each in-

terval and adding amlodipine besylate,

5 to 10 mg daily, thereafter if needed. Of the eligible patients with Stage 1 hypertension who were taking olmesartan medoxomil or olmesartan medoxomil/

hydrochlorothiazide, 89% reached the aggressive goal of 130/85 mm Hg or lower, and of the total patients with Stage 1 hypertension, 56% reached goal on olmesartan medoxomil monotherapy alone. More than one half of the patients with Stage 2 hypertension reached goal taking olmesartan medoxomil or olmesartan medoxomil/hydrochlorothiazide.

Joseph Izzo, Jr., MD, professor of medicine and pharmacology, State University of New York at Buffalo, and a member of the executive committee of the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) commented on the results of the studies, stressing the importance of meeting goals outlined in JNC 7. The two studies demonstrate that tools are available for helping patients reach these goals, he said.

Side Effects of Benicar, Similar Blood Pressure Drugs May Increase Risk Of Heart, Kidney Problems: Study

New research suggests that users of Benicar, Lotensin, Capoten and similar hypertension drugs may face an increased risk of heart problems and kidney failure, raising concerns about the safety of the widely used medications. 

In a study published this week in the medical journal The BMJ, researchers from the U.K. and Denmark warn that some medications used to treat high blood pressure can cause increased concentrations of creatinine in the body, which can lead to problems with the heart and kidneys.

Researchers looked at the effects of a class of drugs known as angiotensin converting enzyme (ACE) inhibitors, which include Lotensin, Capoten, and Monopril, as well as angiotensin II receptor blockers (ARBs), such as Benicar, Avapro and Diovan. The drugs are known to increase concentrations of creatinine in the body, and researchers sought to determine if this had long-term cardiorenal (heart and kidney) outcomes.

Creatinine is a chemical waste product produced by the muscles and then picked up by the blood and then filtered from the body by the kidneys and removed through urination. Individuals with higher muscle mass have higher creatinine levels, but high levels of creatinine are also linked to kidney problems, indicating the chemical is not being removed efficiently.

Previous clinical trials have indicated that a 30% increase in serum creatinine levels appeared to be a cause for concern regarding end-stage renal disease, the study’s authors noted.

This latest study looked at data on 122,363 patients who started treatment with ACE Inhibitors or ARBs from 1997 to 2014. They looked for rates of kidney failure, heart attack, heart failure and death, as well as high creatinine levels.

Researchers found that 2,078 patients had creatinine increases of 30% or more after beginning treatment with the hypertension drugs, which was associated with more than triple the risk of kidney failure, a nearly 50% increased risk of heart attack, a 37% increased risk of heart failure, and nearly double the risk of death. The findings also revealed that the higher the increase in creatinine after beginning the drug treatments, the more pronounced the likelihood of heart or kidney problems, even when the patient did not reach the 30% threshold set by the study.

The findings indicated that the risks were highest in the first year of taking the drugs, and that there was a very significant risk for end-stage renal disease, or kidney failure. They also found that women were more likely to see a spike in serum creatinine levels when starting the drugs than men.

“We found that patients in routine clinical care who started treatment with ACEI/ARB and whose creatinine concentration had increased by 30% or more at their first follow-up monitoring visit were at increased risk for adverse cardiac outcomes and death, compared with patients with more stable creatinine values,” the study’s authors wrote. “Importantly, we showed a ‘dose-response’ relation between the level of increase in creatinine values and risk of adverse outcomes, indicating that all increases below 30% cannot be viewed as safe.”

Benicar Enteropathy Litigation

Several years ago, concerns about the side effects of Benicar and other ARBs emerged, after reports of severe diarrhea and gastrointestinal problems were identified, known as sprue-like enteropathy. However, researchers found that th issues appeared to be limited to the Benicar-family of hypertension drugs, resulting in updated warning information for users and the medical community.

A number of Benicar lawsuits have been filed against the drug maker in recent years, alleging that doctors were unable to link the diarrhea problems to the hypertension drug for years, due to the lack of prior warnings, often resulting in severe and permanent damage to the intestines. Known as villous atrophy from Benicar, this often results in reduced digestive capability, leading to chronic malnourishment and dehydration.

Although the medication had been on the market for more than ten years, when the FDA required the makers of Benicar to update their warning label in July 2013, the agency determined that there was clear evidence that the drug may cause severe diarrhea symptoms months or even years after using the drug without any complications. Prior to these warnings, most doctors did not realize there was any connection between Benicar and diarrhea symptoms reported among long-term users.

Based on adverse event data that has been available to the drug makers for years, FDA officials determined that there is “clear evidence” that Benicar causes some users to suffer chronic diarrhea, abdominal pain, weight loss and other gastrointestinal symptoms, which typically resolve when the medication is no longer used. However, after experiencing these problems over long-periods of time, users may face a risk of suffering

Tags: ACE Inhibitors, Avapro, Benicar, Capoten, Diovan, Heart Attack, Heart Failure, Hypertension, Kidney Failure, Lotensin

Olmesartan and Hydrochlorothiazide | Memorial Sloan Kettering Cancer Center

This document, provided by Lexicomp ^® , contains all the information you need to know about the drug, including the indications, route of administration, side effects and when you should contact your healthcare provider.

Trade names: USA

Benicar HCT

Trade names: Canada

Olmetec Plus

Warning

• Not for use by pregnant women.The use of the drug during pregnancy can cause birth defects or intrauterine death of the child. If you become pregnant or plan to become pregnant while taking this drug, call your doctor right away.

What is this drug used for?

• Used to treat high blood pressure.
• This medicinal product can be used for other indications. Consult your doctor.

What should I tell my doctor BEFORE taking this drug?

• If you are allergic to this drug, any of its ingredients, other drugs, foods or substances.Tell your doctor about your allergy and how it manifested itself.
• If you are allergic to sulfonamides.
• When taking dofetilide.
• Inability to urinate.
• If you are taking a drug containing aliskiren if you have diabetes or kidney disease.

This list of drugs and diseases that may be adversely associated with this drug is not exhaustive.

Tell your doctor and pharmacist about all the medicines you take (both prescription and over-the-counter, natural products and vitamins) and your health problems.You need to make sure that this drug is safe for your medical condition and in combination with other drugs you are already taking. Do not start or stop taking any medication or change the dosage without your doctor’s approval.

What do I need to know or do while taking this drug?

• Tell all healthcare providers that you are taking this drug.These are doctors, nurses, pharmacists and dentists.
• Avoid driving or other activities that require increased attention until you see how this drug affects you.
• To reduce the risk of dizziness or loss of consciousness, get up slowly from a lying or sitting position. Use caution when going up and down stairs.
• If you have high blood sugar (diabetes), your blood sugar should be checked regularly.
• Tell your doctor if you develop signs of high blood sugar, such as confusion, drowsiness, increased thirst and hunger, increased urination, facial flushing, rapid breathing, and fruity breath.
• Check blood pressure as directed.
• Perform blood tests as directed by your doctor. Please consult your doctor.
• This drug may interfere with some laboratory tests.Tell all healthcare providers and laboratory staff that you are taking this drug.
• If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium supplement, consult your doctor.
• If you are on a salt-free or low-salt diet, consult your doctor.
• Talk to your doctor before taking an over-the-counter drug that can increase blood pressure.These drugs include medicines for coughs and colds, diet pills, stimulants, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen, and some naturally occurring drugs.
• Consult your doctor before using alcohol, marijuana or other forms of cannabis, or prescription and over-the-counter drugs that may slow you down.
• If you are taking Colesevelam, take it no sooner than 4 hours after this drug.
• If you are taking cholestyramine or colestipol, talk with your pharmacist about how to take them with this drug.
• Caution should be exercised in hot weather and during vigorous activity. Drink plenty of fluids to prevent dehydration.
• Tell your doctor if you experience excessive sweating, fluid loss, vomiting, or loose stools. This can lead to a drop in blood pressure.
• You can easily get sunburn with this drug.Be careful if you are in the sun. If you get sunburn easily with this drug, talk to your doctor.
• Watch for gout attacks.
• If you have lupus, this drug can make lupus active or make it worse. If any new symptom develops or symptoms worsen, contact your healthcare professional immediately.
• Tell your doctor if you are breastfeeding. It is necessary to consult if the drug poses any risk to the child.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, some people with this drug can have serious and sometimes deadly side effects. Call your doctor or get medical help right away if you have any of the following signs or symptoms, which may be associated with serious side effects:

• Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blistering or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.
• Signs of kidney problems, including lack of urination, change in urine volume, blood in the urine, or rapid weight gain.
• Signs of imbalance in fluid and electrolytes, incl. sudden changes in mood, confusion of thought, muscle pain or weakness, a feeling of disturbed heartbeat, severe dizziness or loss of consciousness, rapid heartbeat, intense thirst, seizures, feeling very tired or weak, lack of appetite, inability to urinate or change in the amount of urine excreted, dryness in mouth, dry eyes, severe stomach upset, or vomiting.
• Signs of a problem with the pancreas (pancreatitis) such as severe abdominal pain, severe back pain, severe stomach upset and vomiting.
• Chest pain.
• Swelling of the arms or legs.
• Diarrhea that does not go away.
• Severe diarrhea.
• Significant weight loss.
• Dark urine or yellowed skin or eyes.
• Fever, chills, sore throat; the appearance of bruising and bleeding for unexplained reasons; a pronounced feeling of tiredness or weakness.
• Anxiety.
• This drug may cause certain eye problems. Left untreated, these problems can lead to long-term vision loss. In cases where such eye problems have occurred, symptoms such as blurred vision or pain in the eyes usually appeared in the period from the first hours to the first weeks after starting the drug. Call your doctor immediately if you experience these symptoms.
• In rare cases, the use of hydrochlorothiazide has been associated with the development of certain types of skin cancer.Protect your skin from the sun and have a skin exam as directed by your healthcare professional. If the color or size of birthmarks or any new or changing skin tumors or growths changes, contact your doctor immediately.

What are some other side effects of this drug?

Any medicine can have side effects. However, many people have little or no side effects.Call your doctor or get medical help if these or any other side effects bother you or do not go away:

• Dizziness.
• Signs of a cold.
• Nausea.

This list of potential side effects is not exhaustive. If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

You can report side effects to the National Health Office.

You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www.fda.gov/medwatch.

What is the best way to take this drug?

Use this drug as directed by your healthcare practitioner. Read all the information provided to you. Follow all instructions strictly.

• Take this medication with or without food.
• Continue taking this drug as directed by your doctor or other healthcare professional, even if you feel well.
• This drug may cause frequent urination. This can lead to sleep disturbances, so try not to take the drug shortly before going to bed.
• Take this drug at about the same time of the day.
• Drink plenty of decaffeinated fluids, unless your doctor tells you to drink less fluids.

What should I do if a dose of a drug is missed?

• Take the missed dose as soon as you can.
• If it is time for your next dose, do not take the missed dose and then return to your normal schedule.
• Do not take 2 doses at the same time or an additional dose.

How do I store and / or discard this drug?

• Store at room temperature in a dry place. Do not store in the bathroom.
• Store all medicines in a safe place. Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs. Do not empty into toilet or drain unless directed to do so. If you have any questions about the disposal of your medicinal products, consult your pharmacist. Your area may have drug recycling programs.

General information on medicinal products

• If your health does not improve or even worsens, see your doctor.
• You should not give your medicine to anyone and take other people’s medicines.
• Some medicines may have different patient information sheets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
• Some medicines may have different patient information sheets. Check with your pharmacist. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
• If you think there has been an overdose of a drug, call a Poison Control Center immediately or seek medical attention. Be prepared to tell or show which drug you took, how much and when it happened.

Use of information by consumer and limitation of liability

This information should not be used to make decisions about taking this or any other drug. Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are appropriate for a particular patient.This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient. Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug. This information should not be construed as a treatment guide and does not replace information provided to you by your healthcare professional.Check with your doctor for complete information on the possible risks and benefits of taking this drug. Use of this information is governed by the Lexicomp End User License Agreement available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Copyright

© UpToDate, Inc. and its affiliates and / or licensors, 2021. All rights reserved.

90,000 What are the common side effects of Benicar?

Common side effects of Benicar® include headache, nausea, swelling of the extremities and joint pain.Many of the side effects of this hypertension medication disappear within a few weeks as the patient’s body adjusts to the medication. Certain side effects, including stool changes, fainting, very rapid swelling and chest pain, are serious and the medication should be stopped until they are relieved. People taking Benicar® should also ensure that it is listed on their patient and pharmaceutical records so that potentially harmful drug interactions can be identified and avoided.

This drug, collectively known as olmesartan, blocks the action of angiotensin, a chemical that normally causes blood vessels to narrow, increasing blood pressure. Patients taking this drug have more open, relaxed blood vessels that allow blood to flow freely and maintain low blood pressure. Doctors will prescribe this medication for hypertensive patients when the condition fails to respond to more conservative measures. The common side effects of Benicar® can vary in severity and some patients have no or very minor side effects, while others may find the medication intolerable.

Patients may experience common Benicar® side effects such as flu symptoms, upper respiratory tract infections, skin rashes, dizziness and diarrhea. Some patients develop tachycardia when the heart beats too fast and may become weak or unstable while taking medication. If the drug is combined with alcohol and foods known to alter blood pressure, patients may experience an adverse reaction. Benicar® side effects can be complicated with concomitant medication and patients should be aware of this.

Serious and less common side effects of Benicar® include angiodemia, when the body swells very quickly as a result of fluid build-up, along with rhabdomyolysis, when muscles begin to break down and the kidneys cannot process protein fast enough, leading to build-up. toxins in the blood. Patients may also have allergic reactions to the drug, causing problems such as difficulty breathing or hives on the skin.

People with biliary obstruction, liver or kidney problems, and congestive heart failure may be poor candidates for Benicar® These patients will be closely monitored for common Benicar® side effects if the physician believes the risks from the medication are balanced against the potential benefits.This drug is also known to cause birth defects and fetal death and should not be used by pregnant women. Women who become pregnant while taking the drug should stop taking it immediately and consult a doctor for further advice.

OTHER LANGUAGES

Benicar’s lawyer – calculation and recall

Benicar’s lawsuit claims that the creators of Benicar did not warn doctors and patients that the drug could cause spru-enteropathy.

Important information about the settlement in Benicar

In August 2017, a $ 300 million agreement was reached with Daiichi Sankyo on behalf of Benicar, Benicar HCT, Azor and Tribenzor who filed claims after suffering sprue enteropathy and other gastrointestinal disorders.

Plaintiffs had to be represented by a lawyer on August 23, 2017 to be eligible to participate in the settlement.

What We Know About Benicar Litigation

Thousands of claims have been filed against Daiichi Sankyo (manufacturer of Benikar) by people suffering from enteropathy and other gastrointestinal diseases as a result of taking Benikar.

In August 2017, a $ 300 million settlement was reached for those suffering from gastrointestinal problems after taking Benicar.

Lawyers argued that if doctors and patients were aware of the risks, they would use a blood pressure drug other than Benicar or be closely monitored for symptoms similar to celiac disease.

What is Benicar Target

Benicar (marketed as Benicar, Benicar HCT, Azor and Tribenzor) is a blood pressure drug that blocks certain receptors known as angiotensin receptors.Angiotensin II is a hormone that causes blood vessels to constrict.

By inhibiting the action of this hormone (as well as decreasing the secretion and production of other hormones involved in the regulation of blood pressure), the blood vessels dilate.

Drugs in this class generate about $ 7 billion in revenues for manufacturers. There are a number of angiotensin receptor blockers (ARBs) on the market, but only Benicar has been implicated in an intestinal disorder known as sprue enteropathy.

Often misdiagnosed as celiac disease, sprue, as enteropathy prevents the intestinal system from properly absorbing nutrients from food. Essentially, a patient who is untreated for this condition literally starves to death.

Benicar Injuries and side effects

A study conducted at the Mayo Clinic by Dr. Joseph Murray linked the development of sprue-like enteropathy with the use of Benicar.Spruce enteropathy is a medical condition that causes severe gastrointestinal symptoms; such as chronic diarrhea, significant weight loss, nausea, and general malnutrition.

The most serious side effects are symptoms that appear to be celiac disease but are actually sprue-like enteropathy.

Dr. Murray conducted a study on 22 patients who used Benicar and were experiencing gastrointestinal symptoms initially diagnosed with celiac disease.However, the patients in the study did not respond to a gluten-free diet, a common form of celiac disease treatment, and did not have detectable tissue transglutaminase in the blood, which is used to positively diagnose celiac disease.

After discontinuing Benicar, all 22 patients experienced relief from gastrointestinal symptoms as well as weight gain. Dr. Murray concluded that Benicar taken by patients is directly related to the gastrointestinal symptoms patients experience. Dr. Murray’s research and findings on the link between Benicar use and sprue-like enteropathy were recently posted online at the Mayo Clinic Proceedings, and Benicar lawyers have begun to file Benicar lawsuits.

Read more

Celiac disease and sprue as enteropathy: Many patients who take Benicar have been inappropriately diagnosed with celiac disease. The damage caused by Benicar (“riser type enteropathy”) mimics celiac disease. Benicar attacks the villi in the small intestine in patients who are susceptible to this reaction, just as in patients who have Celiac disease, their villi will atrophy or flatten after ingesting gluten.

Patients taking Benicar may have had a biopsy taken at the time of endoscopy and this biopsy showed villus or dull villus atrophy.Since villous atrophy is a common finding to show that patients have celiac disease, their gastroenterologists often diagnose their patients with celiac disease. However, many patients found that they did not have Celiac disease, but rather that they were “sprue-like enteropathy” caused by Benicar.

These patients discovered this because a gluten-free diet did not relieve symptoms at all. Rather, the symptoms of these patients were only alleviated after discontinuation of Benicar. Some patients were diagnosed with Celiac disease at the same time they stopped taking Benicar.After being on a gluten-free diet for several years, they realized that they had specifically discussed using their Benicar with their gastroenterologist, that Benicar may have been the culprit for their villous atrophy (and their GI symptoms).

If you are swallowing Benicar and have been diagnosed with celiac disease for the first time while swallowing Benicar, you should consider talking to your gastroenterologist about it.

Cardiac problems: Two large clinical studies also showed an unexpectedly high risk of cardiovascular death in diabetic patients associated with Benicar use.In addition, a study published in the European Journal of Heart showed that Benicar in combination with beta blockers and ACE inhibitors increases the risk of myocardial infarction (heart attacks) and strokes.

Benicar Claim Video

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Benicar Litigation News

Daiichi Benicar Treaty Brings Drug Payments Up to $ 339 Million

“Daiichi officials agreed on Monday to pay $ 300 million to authorize patient suits for their Benicar, Benicar HCT, Azor and Tribenzor drugs.The agreement comes two years after the Japanese company Chuo-Ku paid $ 39 million to resolve the US government’s claims that it paid illegal kickbacks to doctors who were prescribing drugs. Reported to Bloomberg – Benicar $ 339 Million Payout

FDA adds GI warning to Benicar label

“The FDA has ordered the manufacturer of the blood pressure drug olmesartan (Benicar) to add a warning about the risk of a gut condition known as sprue-like enteropathy on the drug label.”Reported in MedPage – FDA Gastrointestinal Warning

FDA and research related to Benicar

FDA approved label changes for Benicar to list sprue reference as enteropathy

The US Food and Drug Administration (FDA) warns that the drug olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) may cause bowel problems known as sprue-like enteropathy.Reported to FDA Benicar Safety Communication

Severe enteropathy associated with olmesartan

Benicar may be associated with severe spruelike enteropathy. Clinical response and histological recovery are expected after drug suspension. Reported at Mayo Clinic – Invokana Spruelike Enteropathy

Olmesartan (Benicar) and drug-induced enteropathy

“The association between olmesartan [Benicar] and sprue-like enteropathy has been observed in several series and reports.Patients 57 to 81 years old, regardless of gender, have experienced weight loss of up to 40 kg while taking this drug. the mechanism that accelerates this adverse effect remains uncertain, it is important to consider olmesartan-associated enteropathy in patients with biopsy-proven atrophy when there is no other cause. Reported in Pharmacy and Therapy – Medicinal Enteropathy

Battle of the Dangerous Drug – Benicar | Levin Papantonio Rafferty

A bit of interesting news is flying under the radar related to a legal skirmish between Japanese drug maker Daiichi-Sankyo, hypertension drug Benicar and several upstarts who would like to produce and sell their own generic versions.A recent federal non-aggression ruling will allow Apotex, Inc. to enter the common market earlier than it would otherwise – but given the ongoing controversy over the drug, it is difficult to understand why this is necessary.

It is currently claimed that olmesartan, used to treat high blood pressure, leads to a life-threatening intestinal disease known as sprue-like enteropathy, continues to cause lawsuits across the country.The main symptoms of this condition are persistent diarrhea and sudden weight loss. This is the result of the victim’s body being unable to absorb nutrients. In fact, the patient can literally starve to death (and some have already died). According to a French study in May 2014, the increased risk of sprue enteropathy begins approximately twelve months after starting treatment; after two years, the risk factor increases by more than 950%. Plaintiffs allege that Daiichi-Sanyo did not alert doctors and patients about the possible side effects of the drug.Indeed, clinical trials lasted only three months, although most patients are prescribed Benicar for much longer.

If true, chances are high that Daichii-Sankyo, like many other Big Pharma corporations, is willing to risk several million dollars in court decisions and human lives to preserve their profits. Terrible, but it happens. The manufacturer of the product realizes that there is a problem, and the bean counters analyze how much it will cost to fix the problem, as opposed to having to pay the court.If the latter is less, the product goes to market, makes a profit, gets hurt or dies — and the money paid to settle lawsuits is considered a cost of doing business.

This Japanese pharmaceutical giant is also not afraid to break the law to win sales. Daiichi-Sankyo recently had to shell out more than $ 39 million to settle allegations that the company paid kickbacks to doctors as an incentive to prescribe its products, including Benicar, in violation of federal false claims law.

Recently, the US Multidistrict Court of Justice referred 15 Benicar claims to federal court in New Jersey, where Daiichi Sankyo and Forest Laboratories are headquartered in the United States. It is more likely that witnesses and pertinent documents will be more readily available in the defendants’ home state, where another XNUMX lawsuits have been filed with the state Supreme Court in the Benicar case.

For more information on the Benicar litigation, visit the Benicar Levin Papantonio Bill website.

Benicar drug, instructions and description of the drug benicar Ukraine

1. Important information
2. Before taking this medicine
3. How do I take Benicar?
4. Benicar Dosing Information
5. What happens if I miss a dose?
6. What happens if I overdose?
7. What should I avoid while taking Benicar?
8. Benicar side effects
9. What other drugs will affect Benicar?
10. Where can I get more information?
11. Video about Benicar

Pronunciation

Common Name: olmesartan (OL me SAR tan)
Names brands : Benicar

What is Benicar?

Benicar (olmesartan) is an angiotensin II receptor antagonist.Olmesartan keeps the blood vessels from constricting, which lowers blood pressure and improves blood flow.

Benicar is used to treat high blood pressure (hypertension) in adults and children who are at least 6 years old. It is sometimes given along with other blood pressure medications.

Benicar may also be used for purposes not listed in this medication guide.

Important Information

Do not use Benicar if you are pregnant. If you become pregnant, stop taking this medication and tell your doctor right away.Olmesartan can cause harm or death to an unborn baby if you take the medicine during your second or third trimester.

Slideshow FDA-Approved Weight Loss Drugs: Can They Help You?

If you have diabetes, do not use olmesartan with any medicine that contains aliskiren (Amturnide, Tekturna, Tekamlo).

Before taking this medicine

You should not take Benicar if you are allergic to olmesartan.

If you have diabetes, do not use Benicar with any medicine containing aliskiren (Amturnide, Tekturna, Tekamlo).

You may also need to avoid taking Benicar with aliskiren if you have kidney disease.

To make sure Benicar is safe for you, tell your doctor if you have:

• liver disease;

• chronic heart failure; or

• If you are dehydrated.

Do not use Benicar if you are pregnant. If you become pregnant, stop taking this medication and tell your doctor right away.Olmesartan can cause harm or death to an unborn baby if you take the medicine during your second or third trimester.

It is not known if olmesartan passes into breast milk or if it could harm a nursing baby. You should not breastfeed while you are taking Benicar.

How should I take Benicar?

Take Benicar exactly as prescribed by your doctor. Follow all directions on the prescription label. Your doctor may occasionally change your dose to make sure you get the best results.Do not take this medicine in larger or smaller amounts, or for longer than recommended.

You can take Benicar with or without food.

Your blood pressure will need to be checked frequently.

You may have very low blood pressure while taking this medicine. Call your doctor if you are sick with vomiting or diarrhea, or if you sweat more than usual.

Continue to use this medication as directed, even if you feel well.High blood pressure is often asymptomatic. You may need to use a blood pressure drug for the rest of your life.

Store at room temperature away from moisture and heat.

Benicar

Dosing Information

Usual Adult Dose for Hypertension:

20 mg orally once a day; May increase dose to 40 mg over two weeks if further reduction in blood pressure is required.

Maximum dose: 40 mg orally once a day

Comments:
-For patients with possible depletion of intravascular volume (for example, in patients receiving diuretics, especially with impaired renal function), initiate this drug under close supervision and consider more low starting dose.
– The daily daily dose provides no additional benefit over the same total dose given once a day.

Usual Pediatric Dose for Hypertension:

6 to 16 years:
-20 to less than 35 kg: 10 mg orally once a day; May increase the dose to 20 mg in two weeks if further lowering blood pressure is required 90 390 -35 kg or more: 20 mg orally once a day; May increase dose to 40 mg in two weeks if further lowering blood pressure is required

Comments:
-For children who cannot swallow tablets, the same dose may be given using temporary suspension.

See also: Dosing information (in more detail)

Read also about the drug Avalide.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it’s almost time for your next scheduled dose. Do not take additional medication to make up for a missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help Line at 1-800-222-1222.

Read also about Xolair.

What should I avoid while taking Benicar?

Drinking alcohol may increase some of Benicar’s side effects.

Do not use potassium supplements or salt substitutes while you are taking Benicar, unless your doctor has told you to.

Avoid getting up too quickly from a sitting or lying position, or you may feel dizzy. Stand up slowly and steadily to prevent falling.

Benicar side effects

Get emergency medical help if you have signs of an allergic reaction to Benicar: hives; labored breathing; Swelling of the face, lips, tongue, or throat.

Call your doctor at once if you have:

• Feeling lightheaded like you might pass out;

• Little or no urination;

• Severe or persistent diarrhea with weight loss;

• Chest pain, fast heart rate;

• Swelling in your hands or feet; or

• High potassium – nausea, slow or unusual heart rate, weakness, loss of movement.

Common Benicar side effects may include:

This is not a complete list of side effects and others may occur. Ask your doctor about side effects. You can report side effects to the FDA at the 1-800-FDA-1088 level.

See also: Side effects (in more detail)

What other medicines will affect Benicar?

Tell your doctor about all of your current medications and what you start or stop using, especially:

• Wheeler;

• lithium;

• NSAIDs (non-steroidal anti-inflammatory drugs) – ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other medicines may interact with olmesartan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Next> Side Effects

Where can I get more information?

• Your pharmacist can provide more information about Benicar.

Video about Benicar

Cardiologist | New Medicine

Cardiologist – a doctor who diagnoses all diseases of the cardiovascular systems.

A specialist in clinical medicine, engaged in the prevention, treatment, rehabilitation, diagnosis of all diseases of the heart and blood vessels.

List of diseases of the cardiovascular system that a cardiologist treats:

– Cardiac arrhythmias,
– Arterial hypotension,
– Atherosclerosis,
– Hypertensive crises,
– Vegetative-vascular dystonia,
– Myocardial infarction,
– Ischemic ,
– Cardialgia,
– Cardiosclerosis,
– Myocardial dystrophy,
– Circulatory failure,
– Neurocirculatory dystonia,
– Pericarditis,
– Congenital heart defects,
– Acquired heart defects,
–
– Vascular crises,
– Angina pectoris (angina pectoris),
– Endocarditis.

Heart.

Complaints of stabbing in the part of the heart, aching pain and heaviness in the left side of the chest, discomfort in it, and in the left shoulder blade and left arm, palpitations, breaks in the heart, acute pain behind the breastbone, shortness of breath on exertion, rare pulse – less 50 beats per minute, swelling without sitting down requires an immediate visit to a cardiologist.

– general blood test,
– general urine analysis,
– alanine aminotransferase,
– aspartate aminotransferase,
– total bilirubin,
– direct bilirubin,
– alkaline photoshosphase,
– gamma-glutamyltransferase,

– urea,
– total cholesterol, HDL cholesterol, with an atherogenic index calculator,
– triglycerides,
– neopterin.

– electrocardiogram of the heart (ECG, electrocardiography),
– daily cardiogram of the heart (daily monitoring of cardiac activity according to Holter),
– daily monitoring of blood pressure,
– echocardiography,
– diagnosis of myocardiopathies,
– genetic markers of cardiovascular myocardial infarction, ischemic heart disease, hypertension, atherosclerosis),
– markers of autoimmune myocardial damage.
– cardiac risk,
– angiography.

To keep your heart healthy for years to come, you must follow several important rules:

1. Do not smoke.

2. Eat correctly and variedly (meat, fish, vegetables, fruits, cereals, whole grain bread, vegetable oils, less fat and sweets) and monitor your weight.

3. Move more, especially in nature: for example, walk at brisk steps for more than 3, and preferably 5 km per day.

4. Control your blood pressure. With a stable increase or frequent drops, it is imperative to undergo an examination.

5. After 40 years, regularly check your natural cholesterol and sugar levels.

6. Drink a glass of red wine with dinner two or three times a week.

High blood pressure, also called hypertension, is a major risk factor for heart disease, kidney disease, stroke and heart failure.

What blood pressure is considered high?

Blood pressure 140/90 and above is considered elevated. This can be called hypertension.

A blood pressure level from 120/80 to 139/89 is called prehypertension. That, in fact, you do not have hypertension, but it is very likely to develop in the future, if you do not make changes in your lifestyle to keep your blood pressure level under control.

Blood pressure less than 120/80 is considered normal.

How can I prevent high blood pressure?

You have the ability to prevent high blood pressure in the following ways:
– Maintaining a healthy weight.Lose weight if you are overweight.
– Increase in physical activity.
– Eating foods that are low in salt.
– Consuming healthy foods such as fruits and vegetables.
– By reducing the amount of alcoholic drinks you drink, if you drink them at all.

These recommendations also apply to the treatment of high blood pressure, although drugs are most commonly included in the treatment.

What is the relationship between blood pressure and weight?

As your body weight increases, your blood pressure rises.In addition, being overweight can increase your likelihood of developing hypertension compared to your normal weight.

More than 60% of the world’s adult population is overweight. By losing weight, you can reduce your risk of developing high blood pressure. Even a small amount of weight loss can make a big difference in the prevention and treatment of high blood pressure.

How can I reduce my weight?

To lose weight, you need to eat slightly fewer calories than you burn.But don’t go on an intense diet to see how quickly you can lose those pounds. The healthiest and most lasting weight loss occurs when you lose 250-500g in a week. By reducing the calorie content of food consumed by 500 calories / day, its amount and increasing physical activity, you can lose about 500g per week.

Here are some tips to help you lose weight and debut on the road to healthy eating:

– Choose foods that are low in calories and fat.Naturally, low-calorie food choices will lower your calorie intake. But did you know that choosing low-fat foods also lowers your calorie intake?

Fat is a concentrated source of calories, so the less fatty foods you eat, the fewer calories you eat.

High-fat foods to avoid include butter, margarine, regular salad dressings, fatty meats, cooked poultry skins, fried foods, whole milk products such as cheese, biscuits, cakes, and fast foods.
– Choose foods rich in starch and fiber. Foods that are high in starch and fiber, such as fruits, vegetables, dried peas and beans, whole grains, noodles, rice, and bread, are excellent substitutes for fatty foods. They contain less calories than fatty foods, but they are also good sources of vitamins and minerals.
– Limit portion sizes. Keeping track of what you eat is not enough for weight loss, quantity also matters. To reduce your calorie intake, you need to limit your portion sizes.Especially try to eat smaller portions of high-calorie foods such as fatty meats and cheese. And try not to deviate from the chosen nutritional strategy, not to come back for an additional portion in a few seconds.
– Keep a food diary. Keep a record of what you eat, when and why you do it. Record whether you snack in front of the TV with some fatty foods or skip breakfast and then eat a hearty lunch. Once you become aware of your eating habits, you can set yourself the necessary goals.
– Physical exercise. Exercise is another important part of the weight loss process. The combination of a reduced intake of fatty and high-calorie foods and exercise will allow you to lose more weight and maintain your weight for a longer time than just dietary restrictions or exercise alone. Exercise can also help lower blood pressure. Physically active people are less likely to develop hypertension than people with low physical activity.You don’t have to be a marathon runner to benefit from physical activity. Even light physical activity, if done every day, can help reduce the risk of heart disease. Try to use the stairs instead of the escalator, park further from the entrance to walk more.

How can I reduce my salt intake?

Americans eat more salt and other sodium foods than they need. Often, after a person with high blood pressure refuses to consume large amounts of salt, his blood pressure drops to normal values.

Salt restriction also prevents high blood pressure.

Some people, such as dark-skinned people and the elderly, are more sensitive to the effects of sodium than others. Since it is almost impossible to predict exactly who will be sensitive to sodium, it makes sense for everyone to limit their salt intake to prevent high blood pressure.

Everyone, especially people with high blood pressure, should consume no more than 6 g of salt per day, which is the equivalent of 2,400 mg of sodium.This is about one teaspoon of salt. But remember to take into account all the salt, including that found in ready-made foods and the salt added during cooking.

You can train your taste buds to enjoy less salty foods. Here are some tips:

– Pay attention to the information on food labels that says the amount of sodium.

– Try to opt for low sodium foods more often.Look for foods that say “no sodium,” “very low sodium,” “low sodium,” “low sodium,” or “unsalted,” on cans, boxes, bottles, and bags.
– Buy fresh, frozen or canned “no salt” foods. Eat fresh poultry, fish, and lean meats more often than canned and prepared foods.
– Use herbs, spices, and salt-free seasoning mixes instead of salt when cooking.
– Cook rice, noodles and hot cereals without salt. Limit your meals of regular or instant rice, pasta, and cereal mixes because they usually contain salt.
– Wash canned foods such as tuna to reduce sodium.

The Dietary Approaches to Prevention of Hypertension (DASH) study found that you can reduce your blood pressure by eating foods rich in cereals, fruits, vegetables, and low-fat dairy products.

How much alcohol can I drink if I have high blood pressure?

Drinking a lot of alcohol can increase your blood pressure. It can also lead to the development of arterial hypertension. Therefore, to prevent high blood pressure, if you do drink alcohol, then limit the amount to two glasses a day.

The American Diet Guide recommends limiting alcohol consumption to one glass a day to maintain a healthy body in women with low body weight.

One glass is equivalent to:
– 50 ml 80% whiskey or 30 ml 100% whiskey,
– 150 ml wine,
– 350 ml beer (regular or light).

You may have heard that certain types of alcohol are good for the heart.

It is believed that people who drink a glass or two a day have lower blood pressure and live longer than those who consume excessive amounts of alcohol. Some people note that wine raises the level of “good” (HDL) cholesterol in the blood, which prevents the buildup of fatty plaques on the walls of the arteries.

While this opinion is possible and correct, there are other aspects: drinking too much alcohol can cause other health problems, such as those that occur in car accidents, liver and pancreas diseases, brain and heart damage, increased risk of developing oncological diseases and alcohol syndrome in the fetus. Alcohol is also high in calories. All this means that you should limit the amount of alcohol consumed.

Should I take any nutritional supplements?

Food supplements can also help prevent high blood pressure. Below is a summary of them.
– Potassium. Eating foods rich in potassium will help protect some people from high blood pressure. You may be getting enough potassium in your diet so you don’t need supplements. Many fruits, vegetables, dairy products, and fish contain sufficient amounts of potassium.
– Calcium. Populations with low calcium intake have high levels of high blood pressure. Despite all this, there is no evidence that taking calcium pills can prevent high blood pressure. It is important to get at least the recommended amount of calcium daily with food – 800-1200 mg per day for adults (pregnant and lactating women need more). Dairy products such as low-fat milk, yogurt, and cheese are good sources of calcium.

Low-fat or non-fat dairy products contain even more calcium than high-fat products.

– Magnesium. A diet low in magnesium can raise your blood pressure. But doctors do not recommend taking too much magnesium to prevent high blood pressure – the amount found in foods with a healthy diet is quite enough.

Magnesium is found in whole grains, green vegetables, nuts, seeds, dry peas and beans.

– Fish oil. Fatty fish like mackerel and salmon contain a type of fatty acid called omega-3 fatty acids. Large amounts of fish oil may help lower high blood pressure, but their role in prevention has not been clarified. It is not recommended to take fish oil capsules because high doses can cause unwanted side effects. These capsules are also high in calories and fat. Most fish, unless they are fried or cooked with added fat, are low in saturated fat and calories and can be eaten frequently.

Should I limit my caffeine intake if I’m worried about my blood pressure?

Caffeine, found in beverages such as coffee, tea, and soda, can cause temporary high blood pressure. In a short time, your blood pressure will return to its original values. If you are not hypersensitive to caffeine and your blood pressure is not dropping, then you should not limit your caffeine intake to prevent high blood pressure.

What medicines are used to treat blood pressure?

If you have hypertension, the lifestyle changes listed above may not be enough to lower your blood pressure. Your doctor may recommend adding medications to these.

Most people with hypertension need more than one drug to lower their blood pressure. Blood pressure lowering drugs are divided into groups:

– Diuretics: Aldactone, Bumex, Demadex, Diuril, Dyrenium, Enduron, Hydrodiuril, Inspra, Lasix, Lozol, Microzide, Midamor, Mykrox, Thalitone, Zaroxolyn.
– Beta blockers: Blocadren, Coreg, Corgard, Inderal, Innopran, Kerlone, Levatol, Lopressor, Normodyne, Pindolol, Sectral, Tenormin, Toprol, Trandate, Zebeta.
– ACE inhibitors: Accupril, Aceon, Altace, Captoten, Lotensin, Mavik, Monopril, Prinivil, Univasc, Vasotec, Zestril.
– Angiotensin II receptor blockers: Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, Teveten.
– Calcium channel blockers: Adalat CC, Calan SR, Cardene, Cardizem, Covera, Procardia, Dilacor, Dynacirc, Isoptin, Norvasc, Plendil, Sular, Tiazac, Verelan.
– Alpha Blockers: Cardura, Catapres, Chlorpres, Hytrin, Minipress, Tenex.
– Vasodilators: Hydralazine, Loniten.

Olmesartan – Russian

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Olmesartan, marketed inter alia under the brand name Benicar, is a drug used to treat high blood pressure, heart failure, and diabetic kidney disease. This is a reasonable initial treatment for high blood pressure.It is taken internally. Versions are available as a combination of olmesartan / hydrochlorothiazide and olmesartan / amlodipine.

Common side effects include dizziness, headaches, diarrhea, and back pain. Serious side effects can include kidney problems, low blood pressure, and angioedema. Use during pregnancy may harm the fetus and use while breastfeeding is not recommended. It is an angiotensin II receptor antagonist that blocks the action of angiotensin II.
It was patented in 1991 and entered medical practice in 2002. It is available as a generic medicine. In 2017, it was the 223rd most commonly prescribed drug in the United States, with over two million prescriptions.

Medical use

Olmesartan is used to treat hypertension. It can be used alone or in combination with other antihypertensive drugs.
The United States Food and Drug Administration (FDA) determined that the benefits of olmesartan continue to outweigh its potential risks when used to treat patients with high blood pressure according to the drug label.

Contraindications

Contraindications for treatment with olmesartan include biliary obstruction. Another serious contraindication is pregnancy reports in the scientific literature, revealing fetal malformations in pregnant women taking drugs based on sartan.

Adverse effects

The incidence of side effects with Benicar (US trade name for olmesartan medoxomil) was reported to be similar to placebo, the only side effect that occurred in 1% of patients treated with it and dizziness was more common than placebo (3% versus 1%).Complete Prescribing Information for Benicar notes that as with all drugs that act directly on the renin-angiotensin system, olmesartan is contraindicated in pregnancy and may cause injury or even death to the developing fetus. In studies of angiotensin II receptor antagonists such as olmesartan, patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen have been reported. Patients with unilateral or bilateral renal artery stenosis have not had long-term use of olmesartan-medoxomil, but similar results can be expected.
Rarely, olmesart can cause serious gastrointestinal problems. Symptoms, which include nausea, vomiting, diarrhea, weight loss, and electrolyte abnormalities, are common among people with celiac disease. Recent studies have suggested that this form of sprue like enteropathy may be caused by inhibition of TGF-β, a cytokine polypeptide that maintains intestinal homeostasis. However, it is still unclear why this effect has never been observed with other ARBs.

Chemistry

Ester prodrug, it is completely and rapidly hydrolyzed to its active acid form.

Dosage and Administration

The usual recommended starting dose of olmesartan is 20 mg once daily. The dose may be increased to 40 mg after two weeks of therapy if a further decrease in blood pressure is desired. Doses above 40 mg do not appear to have a greater effect, and taking twice a day does not offer any benefit over the same total dose taken once a day. Dosage adjustment is usually not required for the elderly, renal failure, or liver dysfunction.In patients with possible depletion of intravascular volume (for example, patients taking diuretics), olmesartan should be started with caution, in such cases, the use of a lower starting dose should be considered. If blood pressure is not controlled by olmesartan alone, a diuretic can be added. Olmesartan can be administered with other antihypertensive drugs. Olmesartan can be taken with or without food.

Society and culture

Olmesartan and Sevikar HCT Combined on the Worldwide Market Daiichi Sankyo, India Abbott Healthcare Pvt.Ltd. under the trade name WinBP, Zydus Cadila under the trade name Olmy, Ranbaxy Laboratories Ltd. under the tradename Olvance, Olsar from Unichem Laboratories and in Canada from Schering-Plow as Olmetec.
Several drugs containing olmesartan and other antihypertensives are available. Teva Pharmaceuticals manufactures a drug containing olmesartan, amlodipine and hydrochlorothiazide for once a day. Benicar HCT is the brand name of a drug containing olmesartan medoxomil with hydrochlorothiazide.