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    Tuesday, July 14, 2009

    Stronger warnings on drugs containing acetaminophen

    In May, 2009 an FDA report recommended stronger warnings and dose limits on drugs containing the painkiller acetaminophen," which is "the active ingredient in Tylenol and a host of other pain relievers." The report "cites an increased risk of liver damage." The FDA working group that issued the report, "made up of 12 top officials in the FDA's Center for Drug Evaluation and Research, recommended lowering immediate-release tablet strength to no more than 325 milligrams from the current 500 milligrams and reducing the single adult dose to 650 milligrams, from 1,000 milligrams.

    The FDA also warned that acetaminophen "overdose was linked to 458 deaths and 26,000 hospitalizations annually from 1990 to 2001," and the drug "is a leading cause of acute liver failure in the US."

    These recommendations cover "both prescription doses and over-the-counter medication" and "include enhanced public information efforts, stronger labels warning of liver side effects, and dose limitations."

    On June 30 the FDA panel recommended that prescription Vicodin [hydrocodone bitartrate and acetaminophen] and Percocet [oxycodone and acetaminophen] be banned, and that over-the-counter Tylenol, Excedrin, Nyquil, and Theraflu contain stronger warning labels...The problem, according to FDA advisors, is that they all contain acetaminophen, which can cause liver damage."

    The FDA Drug Safety Advisory Committee also "recommended lowering the maximum daily nonprescription dose of acetaminophen," Current doses are "at four grams a day or eight extra strength Tylenol a day. The committee...said the maximum single adult dose, should be 650 milligrams. And while extra strength Tylenol recommends two, 500-milligram pills at once, the panel recommends that dose would require a prescription."

    The FDA "panel noted that patients who take Percocet and Vicodin for long periods often need higher and higher doses to achieve the same effect." "The two drugs combine a narcotic with acetaminophen," and the panel's vote to "recommend a ban on the combination drugs was one of 11 it took" at the meeting. The experts also recommended "that the FDA reduce the highest allowed dose of acetaminophen in over-the-counter pills...to 325 milligrams, from 500," and "to reduce the maximum daily dosage to less than 4,000 milligrams."

    The panel "of 37 doctors, pharmacists, and researchers voted on the recommendations after spending two days discussing steps the FDA should take to reduce the number of acetaminophen overdoses."


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