Bans advised for Vicodin and Percocet

BLOOMBERG NEWS

The prescription painkillers Percocet and Vicodin should be banned and use of Tylenol, sold over the counter, should be reduced because the ingredient acetaminophen is linked to liver damage, U.S. advisers said.

Outside advisers to the Food and Drug Administration voted 20-17 Tuesday for the ban on Percocet and Vicodin, which also contain a narcotic. The panel agreed earlier that Johnson & Johnson’s Tylenol should be given in lower doses than now recommended and the extra-strength version should be sold by prescription only.

Acetaminophen, an aspirin alternative in use for five decades to reduce pain and fever, has been a leading cause of liver injury for more than a decade, the FDA said. The agency under President Obama is “taking a harder look at safety” than in previous administrations, said Les Funtleyder, a health care analyst at Miller Tabak & Co. in New York.

“The reality is we’ve known for some time that Tylenol plus alcohol is potentially damaging to livers, and we’ve also known that way too much is damaging to livers,” he said in a telephone interview. “It’s not a huge surprise.”

The advisers represented three committees that give recommendations to the FDA. The agency isn’t bound by what the panel says.

Vicodin, sold by Abbott Laboratories, and its generic equivalents are the most popular drug in the U.S., with 124 million prescriptions last year, according to IMS Health Inc., the data research company. Endo Pharmaceuticals Holdings Inc. sells Percocet.

Acetaminophen overdose was linked to 458 deaths and 26,000 hospitalizations annually from 1990 to 2001, according to an FDA review released ahead of the meeting. The drug is a leading cause of acute liver failure.