What is Imuran and how does it work. What are the main uses of azathioprine. How should patients take Imuran for optimal results. What are the most common side effects of azathioprine. How does Imuran affect the immune system and bone marrow. What precautions should be taken when using this medication. How can patients manage potential risks associated with Imuran therapy.

Understanding Imuran: An Overview of Azathioprine

Imuran, also known by its generic name azathioprine, is a powerful immunosuppressant medication used in various medical conditions. This drug plays a crucial role in organ transplant procedures and the management of certain autoimmune disorders. As with any potent medication, it’s essential to understand its mechanisms, benefits, and potential risks.

What is Imuran and How Does It Work?

Imuran belongs to a class of drugs known as immunosuppressants. Its primary function is to weaken the immune system, which can be beneficial in specific medical scenarios. The drug works by interfering with the production of DNA and RNA, essential components for cell growth and division. This action particularly affects rapidly dividing cells, such as those in the immune system.

Primary Uses of Imuran in Medical Treatment

Azathioprine has several important applications in modern medicine. Its ability to modulate the immune system makes it valuable in various therapeutic contexts.

Preventing Organ Rejection in Transplant Patients

One of the primary uses of Imuran is in organ transplantation, particularly for kidney transplants. After receiving a new organ, the body’s immune system may recognize it as foreign and attempt to reject it. Imuran helps prevent this by suppressing the immune response, allowing the transplanted organ to function normally.

Managing Rheumatoid Arthritis

Rheumatoid arthritis is an autoimmune condition where the body’s immune system attacks healthy joints. Imuran can be effective in managing this condition by reducing the overactive immune response, thereby alleviating symptoms and preventing further joint damage.

Other Autoimmune Conditions

While not explicitly mentioned in the original text, it’s worth noting that azathioprine is also used in treating other autoimmune conditions such as lupus, inflammatory bowel diseases like Crohn’s disease and ulcerative colitis, and certain skin conditions.

Proper Administration and Dosage of Imuran

Correct administration of Imuran is crucial for its effectiveness and safety. Patients should follow their doctor’s instructions carefully to maximize benefits and minimize risks.

How Should Imuran Be Taken?

Imuran is typically taken orally, usually once or twice daily. To reduce stomach upset, it’s recommended to take the medication with food. The dosage is carefully determined based on the patient’s medical condition, weight, and response to treatment.

Duration of Treatment and Expectations

For conditions like rheumatoid arthritis, patients may not see immediate improvements. It can take up to two months before symptoms start to alleviate. Doctors usually assess the medication’s effectiveness after about three months of treatment.

Potential Side Effects and Risks of Azathioprine

Like all medications, Imuran can cause side effects. While not everyone experiences these, it’s important to be aware of potential adverse reactions.

Common Side Effects

Some of the more common side effects of Imuran include:

• Nausea and vomiting
• Temporary hair loss
• Diarrhea
• Joint or muscle pain

These symptoms are usually mild and often improve as the body adjusts to the medication.

Serious Side Effects and Risks

More serious side effects that require immediate medical attention include:

1. Signs of liver disease (persistent nausea/vomiting, abdominal pain, dark urine, yellowing of eyes/skin)
2. Symptoms of infection (fever, chills, persistent sore throat)
3. Easy bruising or bleeding
4. Unusual fatigue or pale skin
5. Swollen lymph nodes
6. Unexplained weight loss
7. Night sweats

These symptoms could indicate severe complications and should be reported to a healthcare provider immediately.

Imuran’s Impact on the Immune System and Bone Marrow

The immunosuppressive nature of Imuran, while beneficial for its intended purposes, can lead to significant effects on the body’s defense mechanisms and blood cell production.

Effects on Immune Function

By weakening the immune system, Imuran can make patients more susceptible to infections. This increased vulnerability necessitates vigilant monitoring and prompt reporting of any signs of infection to healthcare providers.

Impact on Bone Marrow Function

Imuran can affect bone marrow function, potentially leading to a decrease in blood cell production. This can result in anemia, reduced ability to fight infections, and increased risk of bleeding or bruising. Regular blood tests are typically required to monitor these effects.

Cancer Risk Associated with Azathioprine Use

One of the most significant concerns with long-term use of Imuran is the potential increase in cancer risk, particularly certain types of cancer such as lymphoma and skin cancer.

Who is at Higher Risk?

The risk of developing cancer while on Imuran is higher in certain groups:

• Organ transplant recipients
• Children and young adults being treated for inflammatory bowel diseases
• Patients on long-term therapy

Regular monitoring and screening are essential for these high-risk groups.

Symptoms to Watch For

Patients on Imuran should be vigilant for symptoms that could indicate the development of cancer, including:

• Unusual skin changes or new moles
• Unexplained lumps or growths
• Swollen lymph nodes
• Unexplained weight loss
• Persistent night sweats

Any such symptoms should be reported to a healthcare provider promptly.

Precautions and Safety Measures for Imuran Users

Given the potent nature of Imuran and its potential side effects, several precautions should be observed by patients and healthcare providers alike.

Regular Monitoring and Check-ups

Patients on Imuran should adhere to a regular schedule of medical appointments and laboratory tests. These check-ups allow healthcare providers to monitor the medication’s effectiveness and detect any potential complications early.

Pregnancy and Breastfeeding Considerations

Imuran can be harmful to unborn babies. Women who are pregnant or may become pregnant should not handle this medication or breathe the dust from the tablets. The risks and benefits of using Imuran during pregnancy or while breastfeeding should be carefully discussed with a healthcare provider.

Interactions with Other Medications

Imuran can interact with various other medications, potentially altering their effectiveness or increasing the risk of side effects. Patients should inform their healthcare providers about all medications, supplements, and herbal products they are taking.

Managing Imuran Therapy: Tips for Patients

Successful management of Imuran therapy requires active participation from patients. Here are some tips to help optimize treatment and minimize risks:

Adherence to Medication Schedule

Taking Imuran consistently as prescribed is crucial for its effectiveness. Patients should establish a routine, such as taking the medication at the same time each day, to help ensure regular dosing.

Dietary Considerations

While no specific diet is required for Imuran use, maintaining a balanced, nutritious diet can support overall health and potentially help mitigate some side effects. Patients should discuss any dietary concerns with their healthcare provider.

Lifestyle Adjustments

Given the increased risk of infections and skin cancer, patients on Imuran should consider lifestyle adjustments such as:

• Practicing good hygiene to reduce infection risk
• Using sun protection measures to minimize skin cancer risk
• Avoiding close contact with people who have active infections
• Quitting smoking, as it can further increase cancer risk

These adjustments can help manage some of the risks associated with Imuran therapy.

Open Communication with Healthcare Providers

Patients should maintain open and honest communication with their healthcare providers. This includes reporting any new symptoms, side effects, or concerns promptly. Regular follow-ups and discussions about the ongoing benefits and risks of therapy are essential for optimal care.

In conclusion, Imuran (azathioprine) is a powerful immunosuppressant medication that plays a crucial role in organ transplantation and the management of certain autoimmune conditions. While it offers significant benefits, it also comes with potential risks that require careful monitoring and management. By understanding the medication, adhering to prescribed regimens, and maintaining regular communication with healthcare providers, patients can optimize the benefits of Imuran therapy while minimizing potential risks. As with any medication, the decision to use Imuran should be made in consultation with a healthcare professional, weighing the potential benefits against the risks for each individual patient.

Imuran Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Warnings:

Azathioprine may rarely increase your risk of developing certain types of cancer (such as lymphoma, skin cancer). This risk is higher in people using azathioprine after an organ transplant and in children/young adults being treated for certain bowel diseases (such as Crohn’s disease, ulcerative colitis). Keep all medical and lab appointments. Tell your doctor right away if you develop any of the following symptoms: unusual skin changes, change in the appearance/size of moles, unusual growths/lumps, swollen lymph nodes, swollen abdomen, unexplained weight loss, night sweats.

This medication may decrease bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body’s ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: unusual tiredness, pale skin, signs of infection (such as sore throat that doesn’t go away, fever, chills), easy bruising/bleeding.

Warnings:

Azathioprine may rarely increase your risk of developing certain types of cancer (such as lymphoma, skin cancer). This risk is higher in people using azathioprine after an organ transplant and in children/young adults being treated for certain bowel diseases (such as Crohn’s disease, ulcerative colitis). Keep all medical and lab appointments. Tell your doctor right away if you develop any of the following symptoms: unusual skin changes, change in the appearance/size of moles, unusual growths/lumps, swollen lymph nodes, swollen abdomen, unexplained weight loss, night sweats.

This medication may decrease bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body’s ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: unusual tiredness, pale skin, signs of infection (such as sore throat that doesn’t go away, fever, chills), easy bruising/bleeding.

… Show More

Uses

Azathioprine is used to prevent organ rejection in people who have received a kidney transplant. It is usually taken along with other medications to allow your new kidney to function normally. Azathioprine is also used to treat rheumatoid arthritis. In this condition, the body’s defense system (immune system) attacks healthy joints. Azathioprine belongs to a class of drugs known as immunosuppressants. It works by weakening the immune system to help your body accept the new kidney as if it were your own (in the case of an organ transplant) or to prevent further damage to your joints (in the case of rheumatoid arthritis).Talk to your doctor about the risks and benefits of azathioprine, especially when used by children and young adults.

How to use Imuran

Take this medication by mouth as directed by your doctor, usually once or twice daily. Take this medication with food to reduce stomach upset.

The dosage is based on your medical condition, weight, and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

For the treatment of arthritis, it may take up to 2 months before your symptoms get better. Tell your doctor if your condition does not get better after 3 months of treatment.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Side Effects

See also Warning section.

Nausea or vomiting may occur. Taking this medication after meals may help lessen these effects. Temporary hair loss may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: diarrhea, new or worsening joint/muscle pain.

Get medical help right away if you have any very serious side effects, including: symptoms of liver disease (such as nausea/vomiting that doesn’t stop, stomach/abdominal pain, dark urine, yellowing eyes/skin).

This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizure, vision changes.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking azathioprine, tell your doctor or pharmacist if you are allergic to it, or to mercaptopurine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, cancer, certain enzyme disorders (TPMT deficiency, NUDT15 deficiency).

This medication may increase your risk of developing skin cancer. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Your doctor may direct you to avoid phototherapy while you use this product. Ask your doctor for details.

Azathioprine can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your health care professional that you are using azathioprine before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using azathioprine. Azathioprine may harm an unborn baby. Ask about reliable forms of birth control while using this medication. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug are: febuxostat, past or present use of certain cancer drugs (such as cyclophosphamide, melphalan), other drugs that weaken the immune system/increase the risk of infection (such as rituximab, tofacitinib).

Azathioprine is very similar to mercaptopurine. Do not use medications containing mercaptopurine while using azathioprine.

Does Imuran interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, liver/kidney function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you have had an organ transplant, attend a transplant education class or support group. Learn the symptoms of organ rejection such as a feeling of being ill, fever, pain around the transplanted organ, and the signs of a failing transplanted organ (a decrease in the amount of urine with kidney transplant). Get medical help right away if these symptoms occur.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

Imuran 50 mg tablet

Color: yellowShape: double-circleImprint: IMU RAN 50

This medicine is a yellow, double-circle, scored, tablet imprinted with “IMU RAN 50”.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Imuran Information : Azathioprine : Johns Hopkins Arthritis Center

Home / Patient Corner / Drug Information Sheets / Azathioprine (Imuran®) Drug Information Sheet

What is Azathioprine (Imuran®)?

Azathioprine is an anti-inflammatory medicine used to treat rheumatoid arthritis and other inflammatory conditions. It works by suppressing the blood cells that cause inflammation. Azathioprine is used to reduce signs and symptoms of rheumatoid arthritis, such as joint swelling, pain, tiredness, and duration of morning stiffness. Azathioprine is commonly known by the brand name Imuran®.

How do I take it?

Azathioprine is available in 50 mg tablets. The dose is usually one to two tablets each day taken once or on a twice-daily schedule. Your doctor may start you at a low dose, which will be increased over time until you feel better. These should be taken with a meal to reduce upset stomach.

What about side effects?

The most common side effect is nausea and vomiting. This may improve over time, and can get better when the drug is taken after meals or in divided doses.

Itchy rashes, a sore mouth or throat and mouth ulcers may occur. Azathioprine may also irritate the liver.

Azathioprine can lower your immune system and increase your risk of getting infections. Notify your doctor if you have signs or symptoms of an infection and avoid people with contagious diseases.

Azathioprine may cause a decrease in your blood count, such as white blood cells and platelets. Very rarely, azathioprine may cause myelosuppression, which is when the blood cell counts become so low that it may lead to bleeding or severe infection. Your doctor may want to do a test (TPMT testing) to find out if you are at risk for this side effect.

Azathioprine may cause birth defects in children of women taking this drug.

What about other medications?

When you are taking azathioprine, it is very important that your doctors know if you are taking any other medicine. This includes prescription and non–prescription medicines as well as birth control pills, vitamins, and herbal supplements.

Allopurinol (a common gout medicine) may increase azathioprine’s levels in your body. Please tell your doctor if you are taking allopurinol so that the dose of azathioprine can be properly adjusted. Aminosalicylates (olsalazine, mesalamine, sulfasalazine) may interfere with azathioprine and should be discussed with your doctor before beginning treatment.

What else should I know?

It can take up to 8-12 weeks after you start taking azathioprine for you to see improvement in your arthritis.

Blood work will have to be done every 4-8 weeks to monitor your blood counts.

Please tell your doctor if you have a history of any alcohol abuse, hepatitis, yellow jaundice, or liver disease. While on azathioprine your doctor may limit your alcoholic beverage intake. Your doctor may also want to check your blood to make sure you do not have Hepatitis B or C

If you are pregnant or considering having a child, discuss this with your doctor before beginning this medication. Use of an effective form of birth control is critical throughout the course of this treatment and for months after it is stopped. Breast-feeding while taking Azathioprine is not recommended.

Use of this Site

All information contained within the Johns Hopkins Arthritis Center website is intended for educational purposes only. Physicians and other health care professionals are encouraged to consult other sources and confirm the information contained within this site. Consumers should never disregard medical advice or delay in seeking it because of something they may have read on this website.

Imuran – instructions for use, doses, side effects, reviews of the drug:

Description of the drug Imuran ^® (coated tablets, 50 mg) based on official instructions, approved by the manufacturer in 2004

Date approval: 07/30/2004

Contents

• Active substance
• ATX
• Pharmacological group
• Nosological classification (ICD-10)
• Composition and form of release
• pharmachologic effect
• pharmachologic effect
• Pharmacodynamics
• Pharmacokinetics
• Indications
• Contraindications
• Use during pregnancy and lactation
• Dosage and administration
• Side effects
• Interaction
• Precautionary measures
• Storage conditions
• Best before date
• Reviews

Active ingredient

Azathioprine* (Azathioprine*)

ATX

L04AX01 Azathioprine

Pharmacological group

Immunosuppressants

Nosological classification (ICD-10)

ICD-10 code list

• D55-D59 Hemolytic anemia
• D69. 3 Idiopathic thrombocytopenic purpura
• K73 Chronic hepatitis, not elsewhere classified
• L10 Pemphigus [pemphigus]
• M05 Seropositive rheumatoid arthritis
• M30 Polyarteritis nodosa and related conditions
• M32 Systemic lupus erythematosus
• M33 Dermatopolymyositis
• T86 Death and rejection of transplanted organs and tissues

Composition and form of release

Coated tablets	1 tab.
azathioprine	50 mg
excipients: lactose monohydrate; corn starch; pregelatinized starch; magnesium stearate; stearic acid. Tablet shell: hypermellose; macrogol 400 (when granulating and coating, purified water is used as a solvent, which is removed during the production process and is not present in the finished product)

in a blister pack of 25; in a box of 4 blisters.

Pharmacological action

Pharmacological action –

immunosuppressive , anticancer , cytostatic .

Blocks cell division as a result of competition with natural purine bases of DNA and RNA.

Blocks cell division as a result of competition with natural purine bases of DNA and RNA.

Pharmacodynamics

Inhibits the growth and development of immunocompetent cells (lymphocytes, plasma cells), affects the cooperative immune response (T-lymphocytes-macrophages-B-lymphocytes), inhibits the migration of stem cells. In high doses (10 mg/kg) it inhibits the function of the bone marrow, suppresses the proliferation of granulocytes, and causes leukopenia.

Pharmacokinetics

Has a very variable absorption. Bioavailability – 20%, because it quickly turns into 6-mercaptopurine (the bioavailability of the latter is 60%). C _max – 2 hours Creates high concentrations in the tissue of the liver, intestines; the level in the kidneys, lungs, spleen, muscles is equal to that in plasma. T _1/2 – 5 hours

Indications

Organ transplantation, severe rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, chronic active hepatitis, pemphigus vulgaris, periarteritis nodosa, hemolytic anemia, chronic idiopathic platelet penic purpura.

Contraindications

Hypersensitivity (including to 6-mercaptopurine).

Use during pregnancy and lactation

Contraindicated.

Dosage and Administration

Information for healthcare professionals only.
Are you a healthcare professional?

Adults and children.

Use in organ transplantation: up to 5 mg/kg/day on the first day of therapy; maintenance dose – 1-4 mg / kg / day, depending on clinical indications and hematological tolerance. Even in the case of low doses, maintenance therapy with Imuran should be carried out indefinitely, since there is a risk of graft rejection.

Use in relapsing multiple sclerosis: 2-3 mg/kg/day; to achieve the effect, a duration of treatment of more than 1 year may be required. It is not always possible to control the progression of the disease after 2 years of therapy.

Use in other diseases: initial dose of 1-3 mg/kg/day and should be adjusted within this dose range depending on the clinical effect (which may not be obtained within weeks and months from the start of treatment) and changes in the blood count. If a therapeutic effect is obtained, then it is necessary to reduce the maintenance dose to the minimum level at which the effect obtained is maintained. If within 3 months the clinical effect is not achieved, then Imuran should be canceled. However, in inflammatory bowel diseases, treatment should be carried out for at least 12 months, and the therapeutic effect can be achieved after 3–4 months. The maintenance dose can range from less than 1 to 3 mg/kg/day, and is determined by the disease as well as the individual patient’s response.

Experience with Imuran in elderly patients is limited. Although the reported incidence of side effects in the elderly does not exceed that of other patients taking Imuran, they should use the lowest dosages of the recommended dose range. Particular attention should be paid to monitoring hematological parameters, reducing the maintenance dose to the minimum allowable to maintain the therapeutic effect.

In patients with renal and/or hepatic insufficiency, the lowest dose in the therapeutic range should be used.

Side effects

Myelodepression (leukopenia, thrombocytopenia, anemia), megaloblastic erythropoiesis and macrocytosis, nausea, vomiting, anorexia, skin rash, arthralgia, myalgia, drug fever, cholestatic hepatitis, development of secondary infections; in transplant recipients – erosive and ulcerative lesions and bleeding from the gastrointestinal tract, pancreatitis, necrosis and perforation of the intestine, rarely – acute renal failure, hemolytic anemia, acute pulmonary diseases, meningeal reactions.

Interactions

Information for healthcare professionals only.
Are you a healthcare professional?

Enhances the effect of depolarizing muscle relaxants and weakens non-depolarizing ones. Immunosuppression is potentiated by allopurinol, oxypurinol, thiopurinol.

Precautions

A weekly complete blood count is required for the first 8 weeks of therapy. Use with caution in renal and hepatic insufficiency. When combined with allo-, oxy-, thiopurinol, the dose should be reduced by 4 times.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 ° C.

Keep out of reach of children.

Expiry date

5 years.

Do not use after the expiry date which is stated on the package.

Date updated: 11/21/2018

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How drug efficacy is assessed

1. We understand which active ingredient of the drug should be analyzed
2. We are looking for meta-analyses and randomized clinical trials on the active substance in international databases
3. Based on the amount of data collected, we conclude that there is a proven efficacy of the drug

A scientific approach to choosing a drug

Evidence-based medicine is the most advanced method of clinical practice currently used in all developed countries.

A doctor who uses the principles of evidence-based medicine in everyday clinical practice, makes decisions based not on personal experience or the experience of colleagues, will prescribe to the patient only those drugs that have been tested by clinical trials, that is, their effectiveness has been proven.

The meaning of evidence-based medicine

International drug and clinical trial databases

• Worldwide database of medical publications with more than 28 million articles

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• Leading US online resource for original and generic drugs

• World Health Organization’s List of Essential Medicines: WHO Essential Medicines List

A drug is only proven to be effective when there are positive results from high-quality clinical trials

Why is that?

Questions and Answers

How is proven efficacy of a medicinal product determined?

According to the principles of evidence-based medicine, the drug is considered effective only in the presence of positive results of clinical studies with a high level of evidence. The effectiveness of a drug that has even a huge number of studies of a lower level cannot be considered proven.

How are high-quality clinical trials conducted for drugs?

In randomized controlled trials (RCTs), participants are randomly assigned to groups. Some patients fall into the experimental group, while others fall into the control group. Both groups are followed for a certain period of time and analyze the outcomes formulated at the beginning of the study. The effectiveness of treatment is evaluated in comparison with the control group.

An analysis of the combined results of several RCTs is called a meta-analysis. By increasing the sample size in a meta-analysis, more statistical power is provided, and, therefore, the accuracy of assessing the effect of the analyzed intervention.

What is the therapeutic efficacy of drugs?

It is worth separating the concepts of proven efficacy and therapeutic efficacy of drugs. Therapeutic efficacy is the ability to produce an effect (for example, lowering blood pressure), proven efficacy reliably confirms therapeutic efficacy. Thus, in theory, a drug may have therapeutic efficacy without having proven efficacy.

What are the criteria for assessing the proven efficacy of a drug in the MedIQ project?

We use the world’s largest and most reliable databases of drugs and clinical trials as criteria for assessing proven efficacy. An example is the List of Essential Medicines of the World Health Organization. Any drug included in this list is vital for the treatment of various diseases, proven by numerous clinical studies.

If a drug has no studies, but it works for me, is it proven to work?

According to the principles of evidence-based medicine, a drug can be considered proven effective only if there are positive results from clinical studies of a high level of evidence. Your personal experience or the unconfirmed opinion of a doctor cannot be evidence.

I don’t trust the results of your analysis. How can I check them?

The MedIQ evidence-based system is transparent, each user can check which active substance is analyzed and study the results of studies for each criterion.