What is tramadol prescribed for. How should tramadol be used. What are the special precautions for tramadol. What are the potential side effects of tramadol. How should tramadol be stored and disposed of. What should you know about tramadol in case of emergency or overdose.

Understanding Tramadol: A Comprehensive Guide

Tramadol, pronounced as (tra’ ma dole), is a prescription medication that belongs to the opioid analgesic class of drugs. It’s primarily used for managing moderate to moderately severe pain in adults. However, its use comes with several important considerations and potential risks that both healthcare providers and patients need to be aware of.

The Prescription and Usage of Tramadol

Tramadol is prescribed for pain management, but it’s crucial to understand how to use it correctly and safely. Here are some key points about its usage:

• It should be taken exactly as directed by your doctor
• Do not increase the dose or frequency without medical advice
• Discuss pain treatment goals and length of treatment with your healthcare provider
• Consider alternative pain management methods alongside tramadol

Can tramadol be habit-forming? Yes, tramadol may be habit-forming, especially with prolonged use. This risk increases if you or a family member has a history of alcohol abuse, drug use, or mental health issues such as depression.

Tramadol and Respiratory Concerns

One of the most serious potential side effects of tramadol is its impact on breathing. The drug may cause life-threatening respiratory problems, particularly during the first 72 hours of treatment or when the dose is increased.

Who is at Higher Risk?

Certain individuals may be at a higher risk of developing breathing problems when taking tramadol:

• Those with a history of slowed breathing
• People with asthma or lung diseases like COPD
• Individuals who have had head injuries or brain tumors
• Older adults or those weakened by disease

What are the warning signs of respiratory problems? If you experience slowed breathing, long pauses between breaths, or shortness of breath while taking tramadol, seek immediate medical attention.

Tramadol Use in Children and Adolescents

The use of tramadol in pediatric populations is highly restricted due to serious safety concerns:

• It should never be used in children under 12 years old
• It’s not recommended for post-tonsillectomy or post-adenoidectomy pain relief in children under 18
• Use is discouraged in obese children or those with neuromuscular diseases aged 12-18

Why are these restrictions in place? Tramadol use in children has been associated with life-threatening breathing problems and even deaths.

Important FDA Updates on Opioid Pain Medicines

In April 2023, the FDA announced several updates to the prescribing information for opioid pain medicines, including tramadol. These changes aim to promote safer use while recognizing the benefits of these medications when used appropriately.

Key Updates for Immediate-Release (IR) Opioids

• Not recommended for extended periods unless pain remains severe and alternative treatments are insufficient
• Many acute pain conditions in outpatient settings require only a few days of opioid treatment

Updates for Extended-Release/Long-Acting (ER/LA) Opioids

• Reserved for severe, persistent pain requiring extended opioid treatment
• Recommended when alternative treatments are inadequate

What is opioid-induced hyperalgesia (OIH)? A new warning has been added about OIH for both IR and ER/LA opioids, describing symptoms that differentiate it from opioid tolerance and withdrawal.

Tramadol Side Effects and Precautions

Like all medications, tramadol can cause side effects. It’s important to be aware of these potential effects and take necessary precautions:

Common Side Effects

• Nausea and vomiting
• Constipation
• Dizziness
• Headache
• Drowsiness

Serious Side Effects

• Respiratory depression
• Seizures
• Serotonin syndrome
• Allergic reactions

How can you minimize the risk of side effects? Always take tramadol as prescribed, inform your doctor of all other medications you’re taking, and report any unusual symptoms promptly.

Storage and Disposal of Tramadol

Proper storage and disposal of tramadol are crucial for safety:

• Store at room temperature, away from moisture and heat
• Keep out of reach of children and pets
• Do not share your medication with others
• Dispose of unused medication through a drug take-back program or as directed by your pharmacist

Why is proper disposal important? Improper disposal can lead to accidental ingestion or misuse by others, contributing to the opioid crisis.

Emergency Situations and Overdose

Recognizing the signs of a tramadol overdose is crucial. Symptoms may include:

• Extreme drowsiness
• Slow or shallow breathing
• Cold, clammy skin
• Pinpoint pupils
• Slow heartbeat
• Loss of consciousness

What should you do in case of an overdose? If you suspect a tramadol overdose, call emergency services immediately. Naloxone, an opioid antagonist, can be used to reverse the effects of an overdose if administered promptly.

Understanding tramadol’s composition, uses, and potential risks is essential for safe and effective use. Always consult with your healthcare provider for personalized advice and never hesitate to ask questions about your medication. Remember, while tramadol can be an effective pain management tool, it requires careful consideration and responsible use.

Interactions and Contraindications of Tramadol

Tramadol can interact with various substances and medications, potentially leading to serious complications. It’s crucial to be aware of these interactions:

Drug Interactions

• Benzodiazepines (e.g., diazepam, alprazolam)
• Other opioids
• Alcohol
• Certain antidepressants (especially MAOIs)
• Carbamazepine
• Quinidine

Why are these interactions important? Combining tramadol with these substances can increase the risk of severe side effects, including respiratory depression and serotonin syndrome.

Contraindications

Tramadol is contraindicated in certain conditions:

• Severe asthma or breathing problems
• Intestinal blockage or paralytic ileus
• Recent use of MAO inhibitors
• Known hypersensitivity to tramadol

Is tramadol safe during pregnancy and breastfeeding? Tramadol should be used with caution during pregnancy and is not recommended during breastfeeding due to potential risks to the baby.

Tramadol’s Mechanism of Action

Understanding how tramadol works in the body can provide insight into its effects and potential risks:

• Binds to mu-opioid receptors in the brain
• Inhibits the reuptake of norepinephrine and serotonin
• Produces analgesic effects through both opioid and non-opioid mechanisms

How does this dual mechanism contribute to pain relief? The combination of opioid receptor activation and neurotransmitter modulation provides effective pain management while potentially reducing some opioid-related side effects.

Long-Term Use and Tolerance

Long-term use of tramadol can lead to tolerance, where higher doses are needed to achieve the same pain-relieving effect. This can increase the risk of dependence and addiction.

Signs of Tolerance and Dependence

• Needing higher doses for pain relief
• Experiencing withdrawal symptoms when stopping the medication
• Craving the medication
• Using tramadol for reasons other than pain relief

How can you prevent tolerance and dependence? Work closely with your healthcare provider to use the lowest effective dose for the shortest duration necessary. Regular reassessment of your pain management plan is crucial.

Alternative Pain Management Strategies

While tramadol can be effective for pain management, it’s important to consider alternative or complementary strategies:

• Non-opioid pain medications (e.g., NSAIDs, acetaminophen)
• Physical therapy
• Cognitive behavioral therapy
• Acupuncture
• Mindfulness and meditation techniques
• Exercise and stretching programs

Can these alternatives replace tramadol? In some cases, these strategies can be effective alternatives to opioid medications. In others, they may be used in conjunction with tramadol to reduce the required dose.

Tramadol and Mental Health

The use of tramadol can have implications for mental health, particularly in individuals with pre-existing mental health conditions:

• May worsen symptoms of depression
• Can potentially increase the risk of suicidal thoughts or behaviors
• May interact with certain psychiatric medications

How should individuals with mental health conditions approach tramadol use? Close monitoring by healthcare providers is essential, and open communication about any changes in mood or mental state is crucial.

Tramadol in Special Populations

Certain populations may require special considerations when using tramadol:

Elderly Patients

• May be more sensitive to side effects
• Often require lower doses
• Higher risk of falls and cognitive impairment

Patients with Liver or Kidney Disease

• May require dose adjustments
• Higher risk of side effects due to altered drug metabolism

Why is individualized dosing important for these groups? Tailoring the dose to the individual’s specific needs and health status can help maximize benefits while minimizing risks.

The Role of Pharmacogenetics in Tramadol Response

Genetic factors can influence how an individual responds to tramadol:

• CYP2D6 enzyme variations can affect tramadol metabolism
• Some individuals may be “poor metabolizers” or “ultra-rapid metabolizers”
• Genetic testing may help predict response and guide dosing

How does genetic variation impact tramadol efficacy and safety? Understanding an individual’s genetic profile can help healthcare providers tailor treatment plans and predict potential risks or benefits of tramadol use.

Tramadol and the Opioid Crisis

As an opioid medication, tramadol plays a role in the broader context of the opioid crisis:

• Contributes to concerns about opioid misuse and addiction
• Subject to stricter prescribing guidelines and monitoring
• Part of ongoing efforts to balance pain management with public health concerns

What steps are being taken to address these concerns? Measures include improved education for healthcare providers and patients, stricter prescribing practices, and increased access to addiction treatment and naloxone.

Future Directions in Pain Management

Research into pain management continues to evolve, with potential implications for the use of medications like tramadol:

• Development of novel pain medications with reduced addiction potential
• Exploration of personalized medicine approaches to pain management
• Integration of technology in pain assessment and treatment
• Increased focus on multimodal pain management strategies

How might these developments impact the future use of tramadol? As our understanding of pain mechanisms and treatment options expands, the role of tramadol and other opioids in pain management may continue to evolve.

In conclusion, while tramadol can be an effective tool for pain management, its use requires careful consideration of benefits and risks. Patients and healthcare providers must work together to ensure safe and appropriate use, considering individual factors, potential alternatives, and the broader context of pain management and public health concerns. As with any medication, staying informed and maintaining open communication with your healthcare team is key to optimizing treatment outcomes while minimizing risks.

Tramadol: MedlinePlus Drug Information

pronounced as (tra’ ma dole)

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FDA Drug Safety Communication:

[Posted 4/13/2023]

• As part of its ongoing efforts to address the nation’s opioid crisis, FDA is requiring several updates to the prescribing information of opioid pain medicines. The changes are being made to provide additional guidance for safe use of these drugs while also recognizing the important benefits when used appropriately. The changes apply to both immediate-release (IR) and extended-release/long-acting preparations (ER/LA).
• Updates to the IR opioids state that these drugs should not be used for an extended period unless the pain remains severe enough to require an opioid pain medicine and alternative treatment options are insufficient, and that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine.
• Updates to the ER/LA opioids recommend that these drugs be reserved for severe and persistent pain requiring an extended period of treatment with a daily opioid pain medicine and for which alternative treatment options are inadequate.
• A new warning is being added about opioid-induced hyperalgesia (OIH) for both IR and ER/LA opioid pain medicines. This includes information describing the symptoms that differentiate OIH from opioid tolerance and withdrawal.
• Information in the boxed warning for all IR and ER/LA opioid pain medicines will be updated and reordered to elevate the importance of warnings concerning life-threatening respiratory depression, and risks associated with using opioid pain medicines in conjunction with benzodiazepines or other medicines that depress the central nervous system (CNS).
• Other changes will also be required in various other sections of the prescribing information to educate clinicians, patients, and caregivers about the risks of these drugs.

Tramadol may be habit forming, especially with prolonged use. Take tramadol exactly as directed. Do not take more of it, take it more often, or take it in a different way than directed by your doctor. While taking tramadol, discuss with your health care provider your pain treatment goals, length of treatment, and other ways to manage your pain. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or has had an overdose or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse tramadol if you have or have ever had any of these conditions. Talk to your health care provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

Tramadol may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time your dose is increased. Your doctor will monitor you carefully during your treatment. Tell your doctor if you have or have ever had slowed breathing, asthma, or lung disease such as chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways). Your doctor will probably tell you not to take tramadol. Also tell your doctor if you have or have ever had a head injury, brain tumor, or any condition that increases the amount of pressure in your brain. The risk that you will develop breathing problems may be higher if you are an older adult or are weak or malnourished due to disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

When tramadol was used in children, serious and life-threatening breathing problems such as slow or difficulty breathing and deaths were reported. Tramadol should never be used to treat pain in children younger than 12 years of age or to relieve pain after surgery to remove the tonsils and/or adenoids in children younger than 18 years of age. Tramadol should also not be used in used in children 12 to 18 years of age who are obese or who have a neuromuscular disease (disease that affects the nerves that control voluntary muscles), a lung disease, or obstructive sleep apnea (condition in which the airway becomes blocked or narrow and breathing stops for short periods during sleep) as these conditions may increase their risk of breathing problems.

Taking certain other medications during your treatment with tramadol may increase the risk that you will experience breathing problems or other serious, life threatening breathing problems, sedation, or coma. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Your doctor may need to change the dosages of your medications and will monitor you carefully. If you take tramadol with other medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with tramadol increases the risk that you will experience these serious, life-threatening side effects. Do not drink alcohol, take prescription or nonprescription medications that contain alcohol, or use street drugs during your treatment.

Tell your doctor if you are pregnant or plan to become pregnant. If you take tramadol regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby’s doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.

If you are taking the tramadol extended-release tablet or capsule, swallow them whole; do not chew, break, divide, crush, or dissolve them. If you swallow broken, chewed, crushed, or dissolved extended-release preparations, you may receive too much tramadol at once instead and this may cause serious problems, including overdose and death.

Do not allow anyone else to take your medication. Tramadol may harm or cause death to other people who take your medication, especially children.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with tramadol and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

Tramadol is used to relieve moderate to moderately severe pain in adults and children 12 years of age or older. Tramadol extended-release tablets and capsules are only used by people who are expected to need medication to relieve pain around-the-clock. Tramadol is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

Tramadol comes as a tablet, a solution (liquid), an extended-release (long-acting) tablet, and an extended-release (long-acting) capsule to take by mouth. The regular tablet and solution are taken usually with or without food every 4 to 6 hours as needed. The extended-release tablet and extended-release capsule should be taken once a day. Take the extended-release tablet and the extended-release capsule at about the same time of day every day. If you are taking the extended-release tablet or extended-release capsule, you should take it consistently, either always with or always without food. Take tramadol exactly as directed. Do not take more medication as a single dose or take more doses per day than prescribed by your doctor. Taking more tramadol than prescribed by your doctor or in a way that is not recommended may cause serious side effects or death.

Your doctor may start you on a low dose of tramadol and gradually increase the amount of medication you take, not more often than every 3 days if you are taking the solution or regular tablets or every 5 days if you are taking the extended-release tablets or extended-release capsules.

If you are taking the solution, use an oral syringe or measuring spoon or cup to measure the correct amount of liquid needed for each dose. Do not use a regular household spoon to measure your dose. Ask your doctor or pharmacist if you need help getting or using a measuring device,

Do not stop taking tramadol without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking tramadol, you may experience withdrawal symptoms such as nervousness; panic; sweating; difficulty falling asleep or staying asleep; runny nose, sneezing, or cough; pain; hair standing on end; chills; nausea; uncontrollable shaking of a part of your body; diarrhea; or rarely, hallucinations (seeing things or hearing voices that do not exist).

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking tramadol,

• tell your doctor and pharmacist if you are allergic to tramadol, other opiate pain medications, any other medications, or any of the ingredients in tramadol products. Ask your pharmacist for a list of the ingredients.
• tell your doctor or pharmacist if you are taking or receiving the following monoamine oxidase (MAO) inhibitors or if you have stopped taking them within the past 2 weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Your doctor will probably tell you not to take tramadol if you are taking one or more of these medications, or have taken them within the past 2 weeks.
• The following nonprescription or herbal products may interact with tramadol: St. John’s wort and tryptophan. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking tramadol. Do not start these medications while taking tramadol without discussing it with your healthcare provider.
• tell your doctor if you have any of the conditions mentioned in the IMPORTANT WARNING section, a blockage or narrowing of your stomach or intestines, or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to take tramadol if you have any of these conditions.
• tell your doctor if you have or have ever had seizures; an infection in your brain or spine; difficulty urinating; low blood levels of sodium; thoughts about harming or killing yourself or planning or trying to do so; diabetes; pancreas, gall bladder, or thyroid problems; or kidney or liver disease.
• tell your doctor if you are breastfeeding. You should not breastfeed while taking tramadol. Tramadol can cause shallow breathing, difficulty or noisy breathing, confusion, more than usual sleepiness, trouble breastfeeding, or limpness in breastfed infants.
• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking tramadol.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tramadol.
• you should know that this medication may make you drowsy and may affect your coordination. Do not drive a car or operate machinery until you know how this medication affects you.
• you should know that tramadol may cause dizziness, lightheadedness, and fainting when you get up from a lying position. To avoid this, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that tramadol may cause constipation. Talk to your doctor about changing your diet and using other medications to treat or prevent constipation.

Unless your doctor tells you otherwise, continue your normal diet.

If your doctor has told you to take tramadol regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Tramadol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• sleepiness
• headache
• nervousness
• uncontrollable shaking of a part of the body
• changes in mood
• heartburn or indigestion
• dry mouth

Some side effects can be serious. If you experience any of these symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• hives
• rash
• blisters
• hoarseness
• difficulty swallowing or breathing
• chest pain
• swelling of the eyes, face, throat, tongue, lips, hands, feet, ankles, or lower legs
• agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
• nausea, vomiting, loss of appetite, fatigue, weakness, or dizziness
• changes in heartbeat
• nausea, vomiting, headache, confusion, loss of energy, drowsiness, fatigue, restlessness, irritability, muscle weakness, spasms or cramps
• hunger, headache, sweating, shaking of a part of your body that you cannot control, irritability, or difficulty concentrating
• loss of consciousness
• seizures

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www. fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Tramadol may cause other side effects. Tell your doctor if you have any unusual problems while you are taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

While taking tramadol, you should talk to your doctor about having a rescue medication called naloxone readily available (e.g., home, office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood. Your doctor may also prescribe you naloxone if you are living in a household where there are small children or someone who has abused street or prescription drugs. You should make sure that you and your family members, caregivers, or the people who spend time with you know how to recognize an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer’s website to get the instructions. If symptoms of an overdose occur, a friend or family member should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. Your symptoms may return within a few minutes after you receive naloxone. If your symptoms return, the person should give you another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

Symptoms of overdose may include the following:

• decreased size of the pupil (the black circle in the center of the eye)
• difficulty breathing
• slow or shallowing breathing
• extreme drowsiness or sleepiness
• unable to respond or wake up
• slowed heartbeat
• muscle weakness
• cold, clammy skin

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• Rybix^® ODT^¶
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• Ultram^®¶
• Ultram^® ER^¶

• Ultracet^® (containing Acetaminophen, Tramadol)
• Seglentis^® (containing Celecoxib, Tramadol)

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Last Revised – 05/15/2023

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Is tramadol a risky pain medication?

All medications come with a dose of risk. From minor side effects to life-threatening allergic reactions, every decision to take a medication should be made only after the expected benefits are weighed against the known risks. You aren’t on your own in this: your doctor, your pharmacist, and a trove of information are available for your review. Recently, I wrote about how newly approved drugs often accumulate new warnings about their safety, including a gout medication that garnered a new warning due to an increased risk of death. Now, according to a new study, the common prescription pain medication tramadol may earn a similar warning.

Tramadol is unique

When first approved in 1995, tramadol was not considered an opiate (like morphine or oxycodone) even though it acted in similar ways. However, because there were cases of abuse and addiction with its use, the thinking and warnings changed. In 2014, the FDA designated tramadol as a controlled substance. This means that although it may have accepted use in medical care, it also has potential for abuse or addiction and therefore is more tightly regulated. For example, a doctor can only prescribe a maximum of five refills, and a new prescription is required every 6 months.

Compared with other controlled substances, tramadol is at the safer end of the spectrum. Heroin, for example, is a Schedule I drug (high abuse potential and no acceptable medical use). OxyContin is a Schedule II drug (it also has high abuse potential, but has an accepted medical use). Classified as a Schedule IV drug, tramadol is considered useful as a pain reliever with a low potential for abuse.

Despite these concerns, tramadol is one of many common treatments recommended for osteoarthritis and other painful conditions. Several professional societies, including the American Academy of Orthopaedic Surgeons, include it in their guidelines as a recommended drug for osteoarthritis.

New research on tramadol

Researchers publishing in the medical journal JAMA examined the risk of death among nearly 90,000 people one year after filling a first prescription for tramadol or one of several other commonly recommended pain relievers, such as naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), or codeine. All participants were at least 50 years old and had osteoarthritis.

Those prescribed tramadol had a higher risk of death than those prescribed anti-inflammatory medications. For example:

• naproxen: 2.2% of the tramadol group died vs. 1.3% of the naproxen group
• diclofenac: 3.5% of the tramadol group died vs. 1.8% of the diclofenac group
• etoricoxib: 2.5% of the tramadol group died vs. 1.2% of the etoricoxib group.

Meanwhile, people treated with codeine had a similar risk of death to people treated with tramadol.

However, because of the study’s design, the researchers could not determine whether tramadol treatment actually caused the higher rates of death. In fact, the patients for whom tramadol is prescribed could make it look riskier than it truly is.

What is confounding?

Medical research studies may draw faulty conclusions for a number of reasons. Perhaps there were too few participants to find meaningful differences. Maybe the dose of the treatment was too high or too low. But a major source of error in studies is called confounding.

It means an unexpected or external factor — not the one actually being examined — has led to the observed results. For example, let’s say two groups are compared for the risk of heart attack and the group with the higher risk has a less healthy diet. One might conclude that dietary choices led to poorer heart health. But what if those with the unhealthy diet also smoked far more than the healthy eaters? The smoking could be the real culprit. It is a confounder that must be accounted for if the research is to have credibility.

How could confounding affect the study results?

With this new study of tramadol, confounding is a real concern. For example, for a person who has both kidney disease and arthritis, doctors may prescribe tramadol rather than naproxen because the latter may worsen kidney disease. Yet kidney disease could increase the risk of other health problems, including a higher rate of death, which could then be attributed to the tramadol. In other words, the very reason your doctor chose tramadol could make this medication appear riskier than it really is.

The authors of the study acknowledge this possibility and took measures to limit it. In fact, many studies try to avoid these sorts of errors, but they are impossible to avoid completely.

The bottom line

If you take tramadol, talk to your doctor about this study. While the higher rates of death among tramadol users is worrisome, it’s not clear that tramadol is the actual culprit. We’ll need more research to confirm — or refute — the findings. If tramadol does increase the risk of death, we want to understand why and what to do about it (for example, is it an easily avoidable risk, such as an interaction with other medications?). Further research can also help educate doctors and patients about all of the potential risks of tramadol treatment.

Prescription drugs from April 1 in Ukraine – a list of drugs

Which medicines will have to be bought by e-prescription from April 1 (photo: freepik)

Author:
Vasilina Kopytko

On April 1, in Ukraine, many popular drugs began to be sold by electronic prescription. At the same time, the Ministry of Health notes that the list of prescription drugs has not increased, just a new option has become available to Ukrainians – e-prescription.

For more information on which drugs this applies to – read the Styler material.

Painkillers and antipyretics

Prescription painkillers with a strong effect: for example, ketanov, tramadol . And also drugs in ampoules – analgin, noshpa, spazmalgon , but these same drugs in tablets will be on free sale.

Nimesil and its analogues – only by e-prescription. Solutions for anesthesia Infulgan, Anapiron, Paramol, Bupirol, Blimol will also be sold by prescription.

All painkillers based on paracetamol and ibuprofen will be available without a prescription.

Nimesil and its analogues will be sold by prescription only, and paracitamol-based products – without (screenshot)

Hormonal drugs

All hormonal drugs are sold only by prescription. Including hormonal contraceptives and medicines for emergency contraception Postinor. This remedy is most effective on the first day after unprotected intercourse to prevent unwanted pregnancy.

Some hormonal ointments and creams will also be sold by prescription, such as Momederm, Betamethasone, Trimistine, Dermovate, Hyoxysone, Triderm.

And also hormonal drugs for the treatment of the thyroid gland – Thyroxine L-thyroxine or Euthyrox are available by prescription.

Hormonal contraceptives are sold by prescription (screenshot tabletki. ua )

Medicines against hypertension

Drugs to reduce blood pressure such as Captopril, Captopress, Bisoprolol, Enalapril, Amlodipine , Liprazide, Triplixam, Amlodipine are sold by prescription.

Also diuretics Furosemide, Veroshpiron, Furosemide, Afiron, Diacarb.

A prescription is required to purchase drugs to reduce blood pressure (tabletki.ua screenshot)

Medicines for cardiovascular diseases

smaller vials – without.

Magnikor or Cardiomagnyl in packs of 100 tablets sold by prescription, the same drugs in packs of 30 tablets can be bought without a prescription.

For the purchase of ethyl alcohol from 70 ml. also need a prescription. This also applies to the purchase of these drugs: Uperio, Kordaron, Etatsizin, Lidocaine, Magnesium sulfate, Bisoprolol, Vasipil.

Corvalol in 50 ml bottles is available only by prescription (tabletki. ua screenshot)

Cough medicines

for inhalation) – by prescription.

Most drugs for inhalation , including Berodual – by prescription.

Antitussives, not containing codeine , symptomatic herbal preparations (potions, syrups) will be dispensed without a prescription .

All codeine drugs will be available by prescription (tabletki.ua screenshot)

Allergy medicine taken orally (tablets , capsules and injections) remain freely available. But

Suprastin in ampoules only by prescription .

At the same time, allergy ointments and gels, such as Sinaflana ointment, Betasalik, Kremgen, Betamethasone, will be sold by prescription.

Suprastin in ampoules will be sold by prescription, in tablets – without (screenshot tabletki.ua)

Antidepressants lopram etc . will be sold by prescription.

Antidepressants will be dispensed by prescription (tabletki. ua screenshot)

How to check if a drug is prescription

A complete list of all drugs registered in Ukraine is in the State Register of Medicines. There you can check which medicines are available without a prescription, and which ones are available with it.

In the search box, enter the name of the drug, then open the registration certificate of the drug (the leftmost column in the table), and find the line Dispensing conditions in the drug profile. There will be information about the conditions for the sale of this medication.

How to get an e-prescription

A doctor must issue an e-prescription. Upon examination, if necessary, he will register the patient in the electronic health system and form an electronic prescription, indicating the active substance, dosage, duration of the course and instructions for using the drugs.

The doctor then sends the prescription to the patient. It contains a code that will need to be called at the pharmacy. It can only be used once.

You can buy drugs by e-prescription at a pharmacy within 10 days if these are narcotic (psychotropic) drugs, and within 30 days for all other prescription drugs.

What you need to know about buying prescription drugs (screenshot)

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