Painkiller Boundaries Urged By Fda After Education Efforts Failed
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 & Johnsons 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 that 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 FDAs Office of New Drugs, after yesterdays 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 arent 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 agency working group. The agency usually follows panel recommendations, though it isnt 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 groups 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 panels 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 dont realize they shouldnt take over-the-counter Tylenol at the same time, the FDAs 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 Ive seen in preventing” liver injury, said Levine, a gastroenterology professor at the State University of New York Upstate Medical University in Syracuse.
“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.”
Even if the FDA doesnt 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.
Standard of Care
“Theres 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. “Theres no reason why” if that happened, that Acurox “shouldnt be a standard of care.”
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.