The Food and Drug Administration is pondering what to do about the wildly popular painkiller in Tylenol, Excedrin, Vicodin, Percocet and many other commonly used drugs to treat aches and pains and alleviate fevers.
That's after an FDA panel called for sweeping changes yesterday at the conclusion of a a two-day meeting the agency convened to review the safety of acetaminophen, the active ingredient in those drugs.
Acetaminophen is generally very safe and effective, but in excess doses it can cause liver failure. And because acetaminophen is so common -- more than 24 billion doses were sold last year in the United States -- even rare side effects can add up to a lot of problems. Acetaminophen overdoses are the leading cause of liver damage in the United States. The FDA estimates that more than 400 people die each year from overdoses and thousands more are hospitalized.
Because years of public education efforts have failed to alleviate the problem, the panel recommended reducing the highest dose of acetaminophen allowed in over-the-counter medications. The drug is an ingredient in so many products that people often don't realize they are getting multiple doses that could exceed the safe levels. The panel even went as far as to narrowly recommend pulling Vicodin, Percocet and similar products that combine acetaminophen with powerful narcotics from the market altogether.
Now, while the FDA usually follows the advice of its advisory panels, it doesn't have to. And officials say they're not sure yet exactly what they'll do, especially given how split the panel was about pulling drugs like Vicodin, Percocet --and how important these drugs are to so many millions of people. More than 200 million doses of those drugs that combine acetaminophen with narcotics were sold last year in the United States, making them the most common prescribed class of drugs.
The agency could leave drugs like Vicodin and Percocet on the market with stronger, more prominent warning labels. They could also work out a compromise with the companies that make these products where they voluntarily reduce the dosages and take other steps to make them safer.
In the meantime, officials say consumers should pay careful attention to how much acetaminophen they are getting from various products to reduce the chances of suffering complications.
For a good explanation of some of the issues, take at look at this Q&A from the FDA.
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