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Tuesday, June 30, 2009

FDA May Pull Cold Meds from Shelves

FDA May Pull Cold Meds from Shelves

Government experts are scheduled to vote on whether Nyquil and other combination cold medications should be pulled from the market to help curb deadly overdoses.

The Food and Drug Administration has assembled more than 35 experts for a two-day meeting to discuss and vote on ways to prevent overdose with acetaminophen — the pain-relieving, fever-reducing ingredient in Tylenol and dozens of other prescription and over-the-counter medications.

Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA. There are about 200 acetaminophen-related deaths each year.

"It can happen to anybody, but it's very rare," said Dr. Lee Simon, an associate professor at Harvard Medical School, who attended the meeting Monday. "Obviously it's important that we improve the communication about these products because they are ubiquitous, and we still see people inadvertently overdosing."

The drugs that could be pulled off shelves are combination medications, such as Procter & Gamble's NyQuil or Novartis' Theraflu, which mix acetaminophen with other ingredients that treat cough and runny nose.

The FDA is not required to follow the advice of its panels, though it usually does. The panel vote was scheduled for Tuesday afternoon.

Copyright AP

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