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UPDATE: Pain Relievers: Dangerous Side Effect?
UPDATE: FDA panel: eliminate Vicodin, similar drugs.
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UPDATED Tuesday, June 30, 2009 --- 2:50 p.m.
ADELPHI, Md. (AP) -- Government experts say prescription drugs like Vicodin and Percocet that combine a popular painkiller with stronger narcotics should be eliminated because of their role in deadly overdoses.
A Food and Drug Administration panel voted 20-17 that prescription drugs that combine acetaminophen with other painkilling ingredients should be pulled off the market.
The FDA has assembled a group of experts to vote on ways to reduce liver damage associated with acetaminophen, one of the most widely used drugs in the U.S.
Panelists cited FDA data indicating 60 percent of acetaminophen-related deaths are related to prescription products. Acetaminophen is more commonly found in over-the-counter medications like Tylenol and Excedrin.
Copyright 2009 by The Associated Press. All Rights Reserved.
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UPDATED Tuesday, June 30, 2009 --- 11:40 a.m.
ADELPHI, Md. (AP) -- Government experts say the maximum daily dose listed on Tylenol and dozens of other painkillers should be reduced to help curb deadly overdoses.
The Food and Drug Administration's panel voted 21-16 to lower the current maximum dose of nonprescription acetaminophen, which is 4 grams, or eight pills per day. Taking more than that can cause potentially fatal liver damage.
Federal regulators are asking experts to vote on ways to prevent overdose with acetaminophen -- the key ingredient in Tylenol, Excedrin and other medications.
Despite years of educational campaigns and other actions, the FDA says acetaminophen remains the leading cause of liver failure in the U.S.
The panel also is scheduled to vote on other proposals to reduce overdose with the drugs.
Copyright 2009 by The Associated Press. All Rights Reserved.
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UPDATED Tuesday, June 30, 2009 --- 8:00 a.m.
ADELPHI, Md. (AP) -- 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.
The FDA says that 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. There are about 200 acetaminophen-related deaths each year.
Dr. Lee Simon of Harvard Medical School attended Monday's meeting. He says while it's "very rare," such overdoses "can happen to anybody."
Copyright 2009 by The Associated Press. All Rights Reserved.
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Posted Monday, June 29, 2009 --- 12:20 p.m.
WASHINGTON (AP) -- Millions of Americans take Tylenol, Excedrin and other pain relievers containing acetaminophen. And they never think of them as anything but safe. But the Food and Drug Administration is in the middle of two days of hearings focusing on a dangerous side effect of the medications, severe liver damage.
The government says overdoses of acetaminophen send an estimated 56,000 people to the emergency room every year. It's the leading cause of liver failure in the U.S.
The makers of medications with the ingredient are trying to dissuade regulators from placing new restrictions on the drugs -- and possibly even removing some of them from the shelves.
The FDA is asking experts for new ideas on reducing accidental overdoses of Tylenol and other over-the-counter pain relievers. Two options are adding a "black box" warning label to the products and lowering the doses of some of the drugs.
Copyright 2009 by The Associated Press. All Rights Reserved.



