July 1 (Bloomberg) -- Tylenol, a 50-year-old staple of household medicine cabinets, and Vicodin, the most prescribed drug in the U.S., may face new restrictions because of the risk of liver damage tied to the ingredient acetaminophen.

Outside advisers to the Food and Drug Administration voted yesterday in favor of a ban on Vicodin, Percocet and other prescription medicines that combine acetaminophen with a narcotic. The panel also urged that Johnson & Johnson’s Tylenol be given in lower doses than now recommended and the extra- strength version be sold by prescription only.

Acetaminophen, an aspirin alternative used to reduce pain and fever, has been a leading cause of liver injury for more than a decade. The FDA proposed tough strategies to limit overdoses after education efforts failed, a sign it is “taking a harder look at safety” under President Barack Obama than in previous administrations, said Les Funtleyder, a health-care analyst at Miller Tabak & Co., in New York.

“This is not a problem that arose overnight,” said Sandra Kweder, deputy director of the FDA’s Office of New Drugs, after yesterday’s meeting in Adelphi, Maryland. “There is probably not one thing that will reduce the trend of acetaminophen- related liver toxicity. We had taken some actions. They alone aren’t likely to be enough.”

Members of three FDA advisory panels were asked to vote on six options to restrict acetaminophen use that were proposed by an internal working group of the agency. The FDA usually follows panel recommendations, though it isn’t required to do so.

Hospitalizations, Deaths

Acetaminophen overdose was linked to 458 deaths, 26,000 hospitalizations and 56,000 emergency-room visits annually from 1990 to 2001, according to the working group’s report. The drug is a leading cause of acute liver failure in the U.S.

Vicodin, sold by Abbott Laboratories, and its generic equivalents are the most popular drug in the U.S., with about 125 million prescriptions dispensed last year, according to IMS Health Inc., a data research company in Norwalk, Connecticut.

“You have to balance patient safety and treatment options,” said DeAnna DuBose, a spokeswoman for Abbott, in a telephone interview after the panel’s decision. “This particular combination has been around for 30 years. It has a long history of doctors prescribing it and feeling comfortable with it.”

Prescription-combination drugs account for half of acetaminophen overdoses because patients intentionally take too much or don’t realize they shouldn’t take over-the-counter Tylenol at the same time, the FDA’s advisers said. Liver damage caused by acetaminophen has reduced the number of organs available for transplant, said panel member Robert Levine.

‘Best’ Prevention

Banning prescription combinations would offer “the best advantage that I’ve seen in preventing” liver injury, said Levine, a gastroenterology professor at the State University of New York Upstate Medical University in Syracuse.

Endo Pharmaceuticals Holdings Inc., which makes Percocet, looks forward to working with the FDA, said Kevin Wiggins, a company spokesman.

“We introduced a lower-dose tablet, primarily to give physicians a choice for managing the drug with their patients,” Wiggins said yesterday in a telephone interview. “This has been looked at for a long time.”

Endo fell 10 cents to $17.82 at 4 p.m. New York time in Nasdaq Stock Market composite trading. Percocet brought in $130 million for the drugmaker last year, or 10 percent of revenue. Abbott dropped 40 cents to $46.64.

King, Acura Benefit

Even if the FDA doesn’t ban Vicodin or Percocet, adding tougher warnings about liver risks or reducing the amount of acetaminophen they contain may shift demand to a competing painkiller developed by Bristol, Tennessee-based King Pharmaceuticals Inc. and Acura Pharmaceuticals Inc., based in Palatine, Illinois. The companies are waiting for FDA approval of Acurox, a short-acting oxycodone pill designed to deter abuse by causing unpleasant side effects if too much is taken.

“There’s clearly going to be a move away from using acetaminophen,” Corey Davis, an analyst for Natixis Bleichroeder Inc. in New York, said yesterday in a phone interview. “There’s no reason why” if that happened, that Acurox “shouldn’t be a standard of care.”

King gained 19 cents, or 2 percent, to $9.82 in New York Stock Exchange composite trading after a three-day slump. Acura lost 7 cents, or 1.2 percent, to $5.91. Acurox is its first product.

The panel recommended that people take less than 4,000 milligrams of Tylenol or other over-the-counter products containing acetaminophen in a day, and only 650 milligrams, or two Regular Strength tablets, at one time. The usual dose is two 500-milligram Extra Strength tablets. J&J also sells 650- milligram extended-release Tylenol to be taken every 8 hours.

25 Billion Doses

Almost 25 billion doses of all acetaminophen products were sold in 2008. 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. The panel said that dose should be available only with a prescription.

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

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.

Started for Children

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 first- line treatment for bone and muscle pain in the elderly, osteoarthritis of the hip or knee, and in people with heart disease or ulcers.

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.

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

Last Updated: July 1, 2009 16:19 EDT