FDA Panel advises banning Vicodin, Percocet
A special advisory panel to the Food and Drug Administration recommended Tuesday that Vicodin and Percocet—two prescription pain-killers that combine acetominophen with narcotics—should be banned. The panel noted that prolonged use of aceominophen, which is the primary ingredient in Tylenol, causes liver damage in many patients and further recommended that at least seven other medications that combine acetominophen with narcotics should have their use discontinued.
Doctors would still be allowed to prescribe the narcotics, which include oxycodone (found in Percocet) and hydrocodone (found in Vicodin). They would further be allowed to prescribe acetominophen if they wished, but many doctors are already reluctant to prescribe medications that combine acetominophen with narcotics because of its known toxicity to the liver.
In fact, the same panel voted 24 to 13 to recommend that the FDA reduce the highest allowed dose of acetaminophen in over-the-counter pills such as Tylenol to 325 milligrams, from the currently allowed 500 mg. They further voted 21 to 16 to reduce the maximum daily dosage of the drug to less than 4,000 mg.
The FDA is not required to follow the panel’s recommendations but generally does follow such advice. The measure was taken because there have been increasing numbers of accidental deaths from acetominophen in recent years. More than 400 people die and 42,000 are hospitalized every year in the U.S. from acetominophen overdoses. In 2005, American consumers bought 28 billion doses of products containing the ingredient.
Even the currently legally recommended doses of aceotminophen have caused liver damage in some people.
The advisory committee decided not to reduce the number of acetominophen pills allowed to be purchased in a single bottle, since it might provide a greater hardship for the poor and those who live in rural areas who are more likely to buy larger quantities at one time in an effort to save money or out of a need to shop for medications less frequently.
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