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FDA Panel's Painkiller Recommendations: Questions and Answers Print E-mail
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Written by Theresa Maher   
Thursday, 02 July 2009
WEDNESDAY, July 1, (News Locale) - Government experts sent shockwaves through the pharmaceutical industry calling for the ban of two popular painkillers and the reduction in dosage of another. A Food and Drug Administration panel made up of 37 experts has recommended banning Percocet and Vicodin due to their potential liver toxicity issues. The panel also called for limiting the maximum dose of Tylenol to 650 milligrams per day.

Percocet and Vicodin happen to be two of the most popular prescription painkillers across the world However the FDA panel felt that they needed to be pulled off the market to avoid liver damage. The panel’s 20-17 was narrow, but it reflected the concerns of the medical community at large. The FDA is not required to follow the panel's recommendations, but it usually does.

Here are some questions and answers on what exactly the panel is recommending.

Why does the FDA Panel recommend ban on Vicodin and Percocet?
Vicodin and Percocet combine a narcotic with acetaminophen, which is the generic the ingredient found in popular painkiller Tylenol. The latter can cause serious liver damage if taken in high doses.

The problem with Vicodin and Percocet is that patients will have to take larger doses to get the minimum benefits because of the narcotic content. The panel noted that patients who take Percocet and Vicodin will end up having to take excessive doses in order to derive the same effect.

What about Tylenol and Excedrin?
According to available FDA data, acetaminophen damage was the leading causing of acute liver failure between 1998 and 2003 in 22 leading medical centers in the U.S. Furthermore acetaminophen overdoses account for 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths on a yearly basis in the country.

The panel says this is unacceptable and hence the recommended daily dosage of these drugs needs to be reduced.

What dosage is being recommended for Tylenol?
The current dosage is 1,000 milligrams per day, but the panel wants to reduce it to no more than 650 milligrams daily. Additionally the maximum total dose for 24 hours, which is currently 4,000 milligrams, may also be reduced.

What are the other recommendations?
The panel also called for a a black box warning on all acetaminophen products, which means they must essentially warn consumers about the potential for liver damage.

Should I stop taking Tylenol/Vicodin/Percocet?
The best thing would be to consult your doctor and discuss available options especially if you are someone suffering from conditions like arthritis and need to take these medications regularly. However there is no need to panic.
 

 
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