FDA Panel Recommends Ban on 2 Painkillers

The New York Times:

Acetaminophenis combined with different narcotics in at least seven otherprescription drugs, and all of these combination pills will be bannedif the Food and Drug Administrationheeds the advice of its experts. Vicodin and its generic equivalentsalone are prescribed more than 100 million times a year in the UnitedStates….

Thepanel’s 20-17 vote to recommend a ban on the combination drugs was oneof 11 it took at a meeting called to advise the F.D.A. on problemsarising from the extraordinary popularity of acetaminophen. In 2005,American consumers bought 28 billion doses of products containing theingredient.  While the medicine is effective in treating headachesand reducing fevers, even recommended doses can cause liver damage insome people. And more than 400 people die and 42,000 are hospitalizedevery year in the United States from overdoses.

In hopes ofreducing some of these accidents, the committee voted 24 to 13 torecommend that the F.D.A. reduce the highest allowed dose ofacetaminophen in over-the-counter pills like Tylenol to 325 milligrams,from 500. And members voted 21 to 16 to reduce the maximum daily dosageto less than 4,000 milligrams.

But they voted 20 to 17 againstlimiting the number of pills allowed in each bottle, with memberssaying such a limit would probably have little effect and could hurtrural and poor patients. Bottles of 1,000 pills are often sold atdiscount chains.    “We have no data to show that people whooverdose shop at Costco,” said Dr. Edward Covington, a panel memberfrom the Cleveland Clinic Foundation. …

Ina statement, Johnson & Johnson, Tylenol’s maker, said it “stronglydisagrees” with the proposed restrictions on acetaminophen, adding thatthey would be likely to “lead to more serious adverse events asconsumers shift to other over-the-counter products,” like Advil andaspirin.

Linda A. Suydam, president of the Consumer HealthcareProducts Association, said the committee had ignored studies showingthat doses sold by her members — two pills of 500 milligrams, up tofour times a day — were safe. “I think this is a very effective doseand one needed for individuals who experience chronic pain,” she said.

Thecommittee also turned its attention to over-the-counter children’smedicines containing acetaminophen, voting 36 to 1 to limit them to asingle formulation. Right now the liquids are sold in two differentconcentrations, leading to confusion among doctors and parents.  “I don’t think it’s safe to have two formulations out there,” said Dr. Nelson, the acting chairman. . . .

Today's Diane Rehm Show has a further discussion of the FDA panel's recommendation: