An FDA advisory panel voted 20-17 yesterday in favor of banning Vicodin and Percocet, two of the most popular prescription painkillers, as well as seven other acetaminophen/narcotic combinations and their generic equivalents due to toxic effects on the liver.
The narcotic portion of the drugs is not what has experts worried as you might think. It’s the acetaminophen aka Tylenol, which can be toxic to the liver.
The panel also voted that Tylenol should be given in smaller doses and the Extra Strength Tylenol should be sold by prescription only to reduce the dangers of serious liver injury.
The committee voted 24 to 13 to reduce the highest allowed dose of acetaminophen in over-the-counter pills such as Tylenol from 400 milligrams to 325. And members voted 21 to 16 to reduce the maximum daily dose to less than 4,000 milligrams.
But voted 20 to 17 against limiting the number of pills contained in each bottle, with members saying such a limit would probably have little effect and could hurt rural and poor patients.
While the agency is not required to follow recommendations made by the advisory panel, it usually does.
Acetaminophen, an aspirin alternative, has been in use for five decades to reduce pain and fever and has been the leading cause of liver injury for more than a decade, the FDA said.
Vicodin, sold by Abbott Laboratories and its generic copycats are the most popular drugs in the U.S., accounting for more than 100 million filled prescriptions last year, according to the New York Times.
Acetaminophen has been linked to 56,000 emergency room visits, as well as 26,000 hospitalizations and 458 deaths in the 1990s, according to the FDA.
Doctors are accustomed to handing out scripts for these drugs post-surgery, post-trauma and so on. Not to mention everyday use of acetaminophen-containing meds for headaches, fevers, colds and other ailments.
Most panel members agreed that consumers need to be better educated about the risks associated with popular medicines.
Pain-management experts note, that the narcotic portions of these painkillers and the acetaminophen can be prescribed separately. The decision now rests with the FDA. #