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Painkiller Restrictions Urged Because of Threat of Liver Damage

By Catherine Larkin
June 30 (Bloomberg) -- 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 today in Adelphi, Maryland, 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 re commended 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 Barack 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.

Liver Failure
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.

Blaine Davis, a spokesman for Endo, and Abbott spokesman Scott Stoffel didn’t immediately return phone calls for comment.
The shares of Johnson & Johnson, which is based in New Brunswick, New Jersey, fell 16 cents to $56.80 at 4 p.m. in New York Stock Exchange composite trading. Abbott, based in Abbott Park, Illinois, dropped 78 cents, or 1.6 percent, to $47.04. Endo, based in Chadds Ford, Pennsylvania, lost 46 cents, or 2.5 percent, to $17.92 in Nasdaq Stock Market composite trading.

“This is the best advantage that I’ve seen in preventing hepatic toxicity,” or liver injury, said panel member Robert Levine, a gastroenterology professor at the State University of New York Upstate Medical University, in Syracuse, before the vote on Vicodin and Percocet. He said liver damage from acetaminophen has reduced the number of organs available for transplant.

The panel voted 21-16 today that people should take less than 4,000 milligrams of Tylenol or other over-the-counter products containing acetaminophen in a day. The current maximum equals eight Extra Strength, or 500 milligram, tablets or capsules a day.

Extra Strength Restrictions
The 500-milligram tablets account for more than 90 percent of U.S. sales of single-ingredient acetaminophen, according to an FDA review of data from IMS Health. Almost 25 billion doses of the drug were sold in 2008.

“The most important target for our action is unintentional harm, both in adults and in children,” said panelist Karl Lorenz, an internal medicine specialist with the Veterans Affairs Greater Los Angeles Healthcare System. “Education is a weak intervention and we really are looking for more concrete steps.”

The panel voted 24-13 to lower the single adult dose to 650 milligrams, or two regular strength tablets, a reduction of 35 percent. The panel voted 26-11 that the 500-milligram Extra Strength dose should be available through prescription.

Potential for Switch
Limiting access to acetaminophen may inadvertently lead people to switch to ibuprofen, which has its own safety risks including gastrointestinal bleeding, doctors from J&J’s McNeil Consumer Healthcare unit told the panel. They proposed instead adding icons to alert consumers to acetaminophen in combination drugs and revising Tylenol labeling to encourage consumers to start with one caplet per dose and only take two if needed.

Tylenol Elixir for children was introduced in 1955 as the first aspirin-free pain reliever, according to J&J’s Web site. Acetaminophen is now recommended by medical groups as a fi rst- line treatment for bone and muscle pain in the elderly, osteoarthritis of the hip or knee, and in people with heart disease or ulcers.

Popular Drugs
Over-the-counter drugs that combine the painkiller with decongestants, aspirin, caffeine or other medicines represent about half of all acetaminophen sales, the FDA said. These products include Tylenol Cold, Bayer AG’s Midol and Novartis AG’s Excedrin.

J&J is the world’s biggest maker of health-care products. Its sales of over-the-counter drugs, including Tylenol, and nutritional products rose 15 percent to $5.9 billion last year, according to Bloomberg data. The company didn’t specify sales of its Tylenol family of products in its annual report.

Wyeth disputed J&J’s assertion that reports of side effects would increase if consumers switched to over-the-counter ibuprofen products such as its Advil painkiller. The Madison, New Jersey-based company urged FDA to leave acetaminophen combinations on the market and toughen regulatory standards to match those already required for products with ibuprofen or naproxen, another anti-inflammatory medicine.

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net