Is Tramadol a risky pain medication?

All medications carry a certain amount of risk. Every medication comes with a dose of risk, from minor side effects to potentially life-threatening reactions. The benefits and risks should be weighed before deciding to take it. Your doctor, pharmacist and a wealth of information are available to you. I recently wrote that newly approved drugs are often accompanied by new warnings regarding their safety. One example was a gout medicine, which received a new warning due to a higher risk of death. According to a recent study, Tramadol, a common pain reliever prescribed by doctors, may also receive a similar warning.

Tramadol has a unique pharmacological profile.

Tramadol, when it was first approved in 1995 and acted similarly to morphine and oxycodone, wasn't considered an opiate. The thinking and warnings have changed due to the abuse and addiction cases. In 2014, FDA classified Tramadol as a controlled substance. It means that, although Tramadol is used in medicine, there are also risks of abuse and addiction. Therefore it is tightly regulated. A doctor, for example, can only prescribe five refills and a new prescription every six months.

Compared to other controlled substances, Tramadol is on the safer side of the spectrum. Heroin is an example of a Schedule I substance (high potential for abuse and no accepted medical use). OxyContin, for example, is a Schedule II (it has a high abuse potential but an accepted medical use). Tramadol, a Schedule IV substance, is a useful pain reliever with low abuse potential.

Despite these concerns, Tramadol is one of the many treatments commonly recommended for osteoarthritis or other painful conditions. Many professional societies, such as the American Academy of Orthopaedic Surgeons, include it in their guidelines for osteoarthritis.

New research on Tramadol

Researchers published in the medical journal JAMA analyzed the risk of mortality among nearly 90,000.000 people one-year after filling their first prescription of Tramadol or any of the other pain relievers commonly prescribed, such as diclofenac, naproxen, or codeine. The participants all had osteoarthritis and were over 50.

Tramadol users had a greater risk of dying than those prescribed anti-inflammatory drugs. As an example:

  • Tramadol: 2.2% died, compared to 1.3% in the naproxen group
  • Diclofenac: Only 1.8% of those who took diclofenac died, compared to 3.5% in the tramadol groups
  • etoricoxib: 2,5% of tramadol users died, compared to 1.2% in the etoricoxib user group.

Tramadol and codeine both carry a risk of death.

Due to the study's design, the researchers were unable to determine whether Tramadol was the cause of the higher death rates. Tramadol may appear more dangerous than it is because of the patients who are prescribed it.

What is confusion?

For a variety of reasons, medical research studies can draw incorrect conclusions. There may have needed to be more participants for meaningful differences to be found. The dose of treatment could have been too high or low. Confounding is a major cause of error when it comes to studies.

It means that an external or unexpected factor, not the one being studied, has caused the observed results. Let's compare two groups for heart attack risk. The group with a higher risk has an unhealthy diet. You might think that poor dietary habits are the cause of heart disease. What if the people who ate a poor diet also smoked more than those who ate a healthy diet? Smoking could be to blame. It is important to account for this confounder if the research is credible.

What are the possible effects of confounding on study results?

Confusion is a concern in this new tramadol study. If a patient has both arthritis and kidney disease, doctors might prescribe Tramadol instead of naproxen, as the latter could worsen kidney problems. Tramadol could be blamed for causing kidney problems that could lead to other health issues, such as a higher death rate. Tramadol's very selection by your doctor could make it appear more dangerous than it is.

The research authors acknowledge this possibility and have taken steps to minimize it. Many studies attempt to avoid such errors, but it is impossible to avoid them completely.

Bottom line

Talk to your doctor if you use Tramadol about this study. Although the higher death rates among tramadol users are alarming, it is not certain that Tramadol was the cause. More research is needed to confirm or refute the findings. We want to know why Tramadol increases the risk of death and how to prevent it. (For example, could it be an interaction between other medications?) Tramadol is a powerful pain reliever, but it can be dangerous. Further research will help doctors and patients understand the risks associated with Tramadol.