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FDA Recommends Pulling Some Painkillers off the Market

Yesterday an FDA advisory panel recommended that Vicodin, Percocet, and other painkillers combining opioids with acetaminophen be taken off the market. Most of the 400 deaths and 42,000 hospitalizations related to acetaminophen overdoses each year involve such combination products. The risk is of special concern to people who take prescription medications like Vicodin (hydrocodone plus acetaminophen) and Percocet (oxycodone plus acetaminophen) for chronic pain.

Contrary to popular perceptions, it's the over-the-counter ingredient in such prescription painkillers, as opposed to the narcotics, that poses the main health danger for people taking them over extended periods of time. Such patients develop tolerance to the opiods and have to raise their doses, which can be done safely and indefinitely, except that it also increases the danger of liver damage from the acetaminophen.

Doctors who reflexively prescribe opioid-and-acetominophen combinations probably should be more cautious and consider alternative formulations, especially when their patients may be taking these drugs for a long time, and patients should be more aware of the acetaminophen risk. But that does not mean such drugs are never appropriate for anyone in any situation, so a ban seems hard to justify even on paternalistic grounds.

A second recommendation from the advisory panel is based on even shakier reasoning. It said the maximum dose for over-the-counter acetaminophen products such as Tylenol should be reduced from 500 milligrams to 325 milligrams per pill. This proposal does not seem to be based on new data indicating that the current recommended dose is unsafe:

Linda A. Suydam, president of the Consumer Healthcare Products Association, said the committee had ignored studies showing that doses sold by her members—two pills of 500 milligrams, up to four times a day—were safe. "I think this is a very effective dose and one needed for individuals who experience chronic pain," she said.

Instead of adjusting what's considered safe and effective based on new evidence, the dose reduction seems to be aimed at lowering the risk to people who exceed the current guidelines. The change therefore would sacrifice the interests of consumers who follow instructions for the sake of consumers who don't. And if people find that two tablets don't do the trick anymore, won't they be more inclined to take a third or even a fourth, thereby equaling or exceeding the current recommended maximum dose? Alternatively, they may switch to other over-the-counter pain relievers, such as aspirin and ibuprofen, which have their own overdose risks. As one panel member told The New York Times, "If you keep track of what you're taking, none of this is an issue for you."

Reason coverage of the conflict between drug control and pain control here.


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