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.
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. When first approved in , 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 , 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. Researchers publishing in the medical journal JAMA examined the risk of death among nearly 90, 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:. Meanwhile, people treated with codeine had a similar risk of death to people treated with tramadol. In fact, the patients for whom tramadol is prescribed could make it look riskier than it truly is. 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. 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. 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. If you take tramadol, talk to your doctor about this study. 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. As a service to our readers, Harvard Health Publishing provides access to our library of archived content. Please note the date of last review or update on all articles. No content on this site, regardless of date, should ever be used as a substitute for direct medical advice from your doctor or other qualified clinician. I am just shocked to hear all the horror stories!
After being off of the medicine, the doctor put me back on it but at a lower dose to take in conjuction with my other pain medicine to aid in controlling severe pain that i suffer from, and again,……..
Taking this med is like drinking water to me! But my doctor is convinced that it does help! Fortunately for me, i have not been affected in any way, good or bad! I have been taking tramadol since my microdisectomy on June I am one of the few that got no relief from surgery from my nerve pain.
I definitely notice when it is time for my next dose because the pain intensifies. I was doing some research on it and discovered it is addictive. I am on a script of 50 mg 4 times a day as needed. Just the pain subsides measurably for a few hours. It cuts the pain without petting me on Mars. You need to drink a lot of water, and having to get up often at night is a hassle.
You do have to slowly go off it though. I was prescribed Tramadol for severe back pain a couple of years ago. I was unable to sleep due to the pain, which is really a horrible thing! The Tramadol worked beautifully for me.
I felt no pain, and my mood seemed slightly elevated. It was great. That was a mistake. I could not sleep, and was horribly depressed. I cried at silly television dramas; tears streamed down my face.
I felt a cold, deep sense of dread. It was awful. But, once it dawned on me why it was happening, I was able to handle it OK. I take it for back and neck pain. It fogs me up sometimes, especially if I take muscle relaxers too, so sometimes I quit for a while. I went through very similar withdrawal symptoms too, but it seemed to ease up after three nights of no sleep and all that.
By the fourth night I was able to get some decent sleep. CBD seems to help ease it some, btw, in case others read this. I had dental surgery a few years back BIG owie , and the dentist asked if I wanted to try Tramadol gave me a prescription for Tramadol because it was not a narcotic.
Well, of course I wanted to try it. I have been on tramadol since before it was deemed a controlled substance. I had a failed spinal fusion in and have had continuous pain from both that and osteoarthritis.
Several years ago I had shingles down my right leg and developed a neuropathy from that. I am an avid hiker and would not be able to do the things I do without the nerve relief I get from tramadol, taken responsibly twice a day. It also assists in controlling irritable bowel syndrome, which I developed after being treated with Carac for skin lesions.
I do not understand changing this to a controlled substance as I do not get anything but consistent nerve pain relief on a small dose. I get no high whatsoever. No ill side effects. I really think this is an overreaction to the opioid abuse by some which is causing undue stress on prescribing physicians and responsible pain patients.
I am a retired RN and worked 35 years in critical care, a very physical job, thus the spinal fusion. I take my medication responsibly for a good quality of life and to be able to continue to hike, which keeps me healthy! There are risks from any medication a person takes, always the possibility of side effects. Even OTC cold medicines have caused strokes. Need to always know risks and benefits of all medication you take.
If you really question addict has abused other illegal substances in past. For true chronic or intractable pain patients we would do as well as if we ate the buttons off our shirts. Tramadol, sold under brand names such as ConZip and Ultram, was approved by the Food and Drug Administration in but wasn't legally a controlled substance until The researchers add that these findings suggest additional dialogue is needed on the drug's treatment by the DEA.
Thiels says. Previous Mayo Clinic research has led to evidence-based opioid prescribing guidelines developed for specific surgery types and individual patient factors. In some cases, these guidelines have significantly reduced the amount of opioids prescribed while still managing patient pain. The team also has shown that a large portion of patients may not need an opioid prescription after surgery.
Study co-authors are Elizabeth Habermann, Ph. Michael Hooten, M. This research was funded by the Mayo Clinic Robert D. Taking the drug, especially at higher doses or for longer periods of time than a physician recommends, can lead to dependence. In fact, Tramadol has its own risks for the following reasons:. The dual mechanism of action MOA , consisting of binding to the opioid receptors in the brain and inhibiting serotonin and norepinephrine reuptake, causes unpredictable rates of metabolism in different people.
This can lead to differing rates of effectiveness and toxicity, making predictions about the safety of the drug inaccurate. The risks associated with the dual MOA include atypical reactions as compared to other opioids, as risks for both opioid medications and Selective Serotonin Reuptake Inhibitors SSRIs are incurred when Tramadol is used. This condition is called serotonin syndrome. Symptoms of serotonin syndrome include: 6. Hypoglycemia low blood sugar : People who have diabetes and who take Tramadol may experience an abnormal decrease in their blood sugar levels.
This can lead to shakiness, weakness, fainting or lightheadedness, anxiety, heart palpitations, and excessive hunger, among other symptoms. Seizures : People who have never had seizures before may be at increased risk of having seizures while on the drug.
Tramadol toxicity : Tramadol is processed in the liver and excreted from the body through the kidneys. People who have kidney or liver disease may not be able to process and remove the drug from the body as other people do, leading to toxic levels of build up. Ultra-rapid metabolism : This happens when Tramadol is metabolized in the body too quickly, resulting in stronger side effects, including slowed or stopped breathing.
Children are especially prone to this health risk. Breathing problems : People who already have lung or breathing conditions may experience more difficulty breathing when using Tramadol.
Those who have asthma or lung disease, or who are over the age of 75, are at higher risk for breathing problems. One of the more dangerous risks of Tramadol is its potential to interact with other drugs. These interactions can cause blood levels to contain too much of the drug, leading to adverse side effects or Tramadol toxicity. Interaction may also cause the drug to be ineffective and possibly lead to withdrawal symptoms.
Some of the drugs that interact adversely with Tramadol include: 7. Tramadol abuse has increased rapidly over the past several years, in part because of the misconception that Tramadol is a safe medication. This number accounts for 8. People who abuse Tramadol are at risk for overdose, and possibly also for death, due to the health risks mentioned above.
The Centers for Disease Control CDC reports that drug overdose deaths involving synthetic opioids, including Tramadol, are on the rise.
The number of people who require emergency medical care for Tramadol abuse is concerning. Tramadol is a medication that is often combined with other medications and is often abused along with other substances. The good news is that the trend of people abusing or overdosing on Tramadol appears to be decreasing.
The following chart shows the number of exposures to Tramadol reported by the American Association of Poison Control Centers from to Of note here is the decrease in reported exposures between and , which may reflect the overall decrease in the use of prescription opioids.
The number of deaths reported has also decreased, from 9 in to 1 in Because Tramadol is an opioid, it is addictive, like other opioids. If use is stopped suddenly, withdrawal symptoms may occur. These include:. Withdrawal symptoms may also occur if Tramadol is used in combination with opioid antagonist drugs. These drugs are designed to counteract the effects of opioids.
If taken with Tramadol, these drugs will negate the effects of the opioid portion of Tramadol, making it less effective and causing withdrawal symptoms. This drug should not be used for pain control when taking the following drugs designed to counter the effects of opioids: That being said, these drugs may be effective when treating dependence on Tramadol. A case study showed how a woman successfully recovered from Tramadol dependence by using a combination of buprenorphine and naloxone.
If these symptoms are severe, a person may require immediate medical care. A better approach to stopping Tramadol use is to work with a physician or other medical professional to gradually reduce the dose, keeping the symptoms of withdrawal mild or absent until use stops. This is called tapering. There is no set amount of time over which tapering of Tramadol should occur, but the average is 2 to 3 weeks. People who misuse or abuse Tramadol may need more intensive treatment to end the abuse, especially if the drug is being abused along with other, more potent substances.
This type of treatment may be done through outpatient treatment with a qualified physician, or in an inpatient facility if withdrawal symptoms are severe or dangerous.
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