FDA panel to vote on painkiller restrictions, Nyquil and others may be pulled
source: http://www.sfgate.com/cgi-bin/article.cgi?f=/n/a/2009/06/29/national/w052944D68.DTL&tsp=1
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- WakeUpPeople
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Government experts are scheduled to vote Tuesday on whether Nyquil and other combination cold medications should be pulled from the market to help curb deadly overdoses.
As the second day of the Food and Drug Administration's meeting began, the agency is asking more than 35 experts 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.
Acetaminophen is one of the most widely used drugs in the U.S. Many patients find it easier on the stomach than other painkillers like ibuprofen and aspirin, which can cause ulcers.
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 Monday's meeting. "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 vote is scheduled for Tuesday afternoon.
Manufacturers could lose hundreds of millions of dollars in sales if combination drugs are pulled from the market. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80 percent of the market comprised of over-the-counter products.
As the second day of the Food and Drug Administration's meeting began, the agency is asking more than 35 experts 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.
Acetaminophen is one of the most widely used drugs in the U.S. Many patients find it easier on the stomach than other painkillers like ibuprofen and aspirin, which can cause ulcers.
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 Monday's meeting. "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 vote is scheduled for Tuesday afternoon.
Manufacturers could lose hundreds of millions of dollars in sales if combination drugs are pulled from the market. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80 percent of the market comprised of over-the-counter products.
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- Apocalipstick
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slvrGelatin
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Look out for CODEX!!!!
- 2 years ago
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slvrGelatin
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slvrGelatin
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This is too ironic. Doctors push and push this substance to people and now they decide to pull these drugs. Overdose is the main reason. Usually people don't accidentally drink the whole bottle.... Do they? Those people know what they're doing. They're killing themselves. Why don't they try pull corn syrup which has traces of mercury? Why don't they do something about our water? Why don't they pull vaccines? These guys are useless. More tax dollars to negligence.
- 2 years ago
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slvrGelatin
