In a very close 20-17 vote, a federal panel recommended the FDA pull percocet, vicodin and several other prescription painkillers off the market because they contain acetaminophen which taken in large dose over a long period of time can result in death.
Percocet has been on the market for 33 years. Don't you think they should have caught this deadly side effect a bit sooner?
In 2005, American consumers bought 28 billion doses of products containing the ingredient. While the medicine is effective in treating headaches and reducing fevers, even recommended doses can cause liver damage in some people. And more than 400 people die and 42,000 are hospitalized every year in the United States from overdoses. In hopes of reducing some of these accidents, the committee voted 24-13 to recommend that the FDA reduce the highest allowed dose of acetaminophen in over-the-counter pills like Tylenol to 325 milligrams, from 500. And members voted 21-16 to reduce the maximum daily dosage to less than 4,000 milligrams.
Houston Chronicle
While its standing operating procedure for the FDA to follow the recommendations of its advisory boards,it isn't legally obligated to.
May the lobbying begin. Not just from the pharmas but from physicians as well. If they really take these drugs off the market, it will be much harder to regulate patient's pain.
The advisory board also recommends that the FDA change the amount of Acetaminophen allowed in over the counter drugs like Tylenol,NyQuil and Excedrin.Yikes-all of a sudden this drug sounds scary, over-the-counter or not. Should I even use it? Yes, says Dr. Robert Brown at NY’s Presbyterian Hospital who was quoted in McKenzie’s WORLD NEWS piece as saying “(Acetaminophen) is so popular because it’s effective and, compared with other pain relievers, it’s easier on the stomach and has virtually no side effects when taken at the right dose.” Dr. Tim Johnson concurs telling Charles Gibson on WORLD NEWS “well I do want to emphasize that overall, it is a very safe and effective drug, widely used for 50 years now.
Clem's Chronicles, ABC News
Now, the FDA doesn't have to ban these products.Given the potential loss in revenues and the lack of substitute drugs, it seems very unlikely that a full blown ban will go into effect. What I think could happen is the FDA will require much stronger warning labels on this product and it could require the pharmas to provide an extensive consumer education campaign to make them aware of the dangers of not following recommended dosages. But a complete ban? Just not seeing it.the FDA advisory panel voted 21-16 to lower the maximum daily dose of nonprescription acetaminophen, which is currently 4 grams -- equal to eight pills of a drug such as Extra Strength Tylenol. The panel was not asked to recommend another maximum daily dose. The panel also voted 24-13 to limit the maximum single dose of acetaminophen to 650 milligrams. The current single dose of Extra Strength Tylenol, for instance, is 1,000 milligrams. The panel also voted 26-11 to make the 1,000-milligram dose of acetaminophen available only by prescription.
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