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Acetaminophen Worries

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.

By Rob Stein  |  July 1, 2009; 9:01 AM ET
Categories:  Family Health , General Health  
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Comments

Where has the FDA been all these years? aren't they supposed to be protecting us not the pharmaceuticals. There is a related post at http://www.iamsoannoyed.com/?p=2017

Posted by: carlyt | July 1, 2009 2:42 PM | Report abuse

Have the idiots at the FDA gone mad. Acetaminophen misuse is NOT the leading cause of Liver failure--its ALCOHOL by 155 to 1 . I am nearly 70 years old and was seriously injured 20 years ago in an industrial accident. I take both Percocet and Vicodin and lead a fairly normal,pain free life . I do not know what will happen to me if these marvelous,safe products are pulled because someone cant see the forest because of all the trees. Address the alcohol issue (which killed 75,000 + last year ) and leave these products alone-anything taken in dosages beyond what your Doctor sets are dangerous , don't take on a product that may kill fewer people in a year than roller skating and disregard the leading cause of liver related deaths.

PS My physican orders liver enzymes test on me every 6 months and my values are perfect.

Posted by: jkbarden | July 1, 2009 4:10 PM | Report abuse

More on acetaminophen in the news:
FDA Meets on Acetaminophen: http://www.newsinferno.com/archives/7607#more-7607

Posted by: Cynthia111 | July 1, 2009 4:37 PM | Report abuse

I don't think that the problem is acetaminophen -- the problem is people are misusing the medication. It can be used safely and be quite effective; you just have to follow the dosing rules.

For those of us with a history of gastric problems who cannot take aspirin, nsaids, ibuprofen, etc. it is the ONLY medication that is effective and safe.

I have been using it for years -- following the guidelines -- and have no problems at all with my liver, but I've had gastric bleeding from those other medications.

But, if I have to take one of the other types of medication, my choice will be ulcers or living with pain.

Posted by: abby0802 | July 1, 2009 5:13 PM | Report abuse

I agree -- the problem is not its use, teh problem is misuse.

By the logic that any misuse = need to make it Rx only, you could probably pull most OTC medications and make them ALL Rx only. (Which, for many reasons, is neither practical nor terribly bright, not to mention a bit totalitarian and Big-Brother feeling.)

Posted by: forget@menot.com | July 2, 2009 8:34 AM | Report abuse

Actually the problem is all the ridiculous combinations that drug manufacturers invent. It's almost impossible to find a decongestant without acetaminophen. Why can't they just sell the monodrugs? I don't think it helps anybody to have to choose between "Cough and cold", "Cold and flu", "Flu and allergies", "Nighttime cold", "Daytime cold", "Flu and sore throat", "Cold and sorethroat", etc, etc, etc.

Posted by: ogs123 | July 3, 2009 5:47 PM | Report abuse

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