Could Tramadol be 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.

Source: Havard Blog