A panel of experts has recommended that the FDA should ban the prescription painkillers Vicodin and Percocet, and that the “safe maximal” dose of Tylenol be reduced significantly.
The panel voted 20 to 17 to ban on the 2 narcotic-acetaminophen combo drugs.
It also recommended that extra-strength Tylenol be made available by prescription only, and that dosing recommendations for children’s Tylenol be reexamined.
The problem with all of them, according to the panel, is acetaminophen, which has long-since been linked to liver damage.
The group recommended that the FDA “send a clear message that there’s a high likelihood of overdose from prescription narcotics and acetaminophen products,” Sandra Kweder of the FDA’s Office of New Drugs said at a press conference.
Acetaminophen overdoses prompted 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths in the 1990s, the FDA reported. It is also, according to the CDC, by far the most common cause of acute liver failure, which strikes about 1,600 people each year.
Acetaminophen is also found in NyQuil, Pamprin, Allerest and dozens of other OTC remedies for colds and flu, headache, menstrual symptoms, allergies, insomnia, arthritis and other minor ailments.
The panel decided against recommending a ban on OTC drugs containing acetaminophen, since they cause less than 10% of all overdoses with this drug.
Abbott Laboratory’s Vicodin and its generic congeners are the most frequently prescribed drugs in the US, according to IMS Health. Nearly 124 million prescriptions were written for the juice last year alone.
The FDA is not required to follow the recommendations of its panels, though it usually does.