Column: There‘s trouble with tramadol that patients should know – The Columbus Dispatch

On Jan. 15, an advisory committee of the Food and Drug Administration split down the middle over whether to approve a combination drug containing the opioid tramadol and celecoxib (a prescription anti-inflammatory drug similar to ibuprofen). Physicians for Rational Opioid Prescribing and other groups opposed approval because tramadol is a dangerously unpredictable and addictive opioid.
Unfortunately, some physicians don’t even know that tramadol is an opioid. There’s a reason for this ignorance. Tramadol was originally approved by the FDA in 1995 with none of the prescribing restrictions that opioids have, so prescribers assumed it was nonaddictive. It was classified as a controlled substance only in 2014 and is in the lowest-rung category of controlled substances, along with common sleeping pills like Ambien. Even physicians who know that tramadol is an opioid consider it a weak opioid — and that’s true when it is injected. When swallowed — far and away the most common use — tramadol is transformed by enzymes in the gut and liver into a potent opioid similar to morphine.
That should make tramadol good for pain, but instead, tramadol is an unreliable painkiller. That’s because 1 in 14 people lack the enzyme to transform tramadol to its most active form, so they won’t get either pain relief or a high from the drug. One in 10 people, however, are superfast metabolizers, so they will get a rush of opioid with each dose. Effects vary in everyone else.
The faster a drug acts, the more addictive it is, and for fast metabolizers, tramadol is a highly addictive drug. Tramadol addiction has been well-documented in Africa, Asia and the Middle East. Tramadol is becoming a more commonly prescribed opioid than other opioids, perhaps because physicians think it’s a safer, nonaddictive drug. It isn’t: As with other opioids, a few weeks of use can lead to opioid dependence. About 1 in 8 people who receive a tramadol prescription will still be taking an opioid a year later.
Because the same dose of tramadol has very different effects in different people, tramadol is highly problematic. Tramadol can cause all of the harms that other opioids do: addiction, suppressed breathing and death. Unlike other opioids, tramadol also can cause seizures and low blood sugar. And while stopping any opioid can cause withdrawal symptoms that feel like the flu, 1 in 8 people who try to stop tramadol suffer unusual withdrawal symptoms that can include hallucinations, panic attacks and paranoia.
To add to the bad news, it is not even clear that tramadol works well for pain. Many studies have found tramadol no more effective than over- the- counter painkillers for either chronic pain, like arthritis, or back pain or acute pain, including dental surgery.
The bottom line is that tramadol is an unpredictable, addictive opioid with additional risks that opioids don’t have. We hope that the FDA will not approve the tramadol combination drug discussed in the advisory committee meeting, or for that matter, any tramadol drug. And for tramadol alone? Physicians shouldn’t prescribe it and patients shouldn’t take it.
Adriane Fugh-Berman, M.D., directs PharmedOut, a rational prescribing project of Georgetown University Medical Center, and is on the board of Physicians for Responsible Opioid Prescribing.


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