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FDA Advisers Recommend Smaller Doses of Acetaminophen
Date:6/30/2009

The drug can cause liver damage if used improperly

TUESDAY, June 30 (HealthDay News) -- FDA advisers voted Tuesday to recommend that the maximum dose for Tylenol and other pain medications should be reduced to help curb deadly overdoses.

The advisers recommended lowering the maximum dose of over-the-counter acetaminophen -- the key ingredient in Tylenol, Excedrin and other medications.

Part of the problem, according to an FDA report released last month, is that severe liver damage can result from a lack of consumer awareness that acetaminophen can cause such injury. Also, many people may take more than the recommended dose of over-the-counter pain relievers in the mistaken belief that taking more will be more effective against pain without posing health risks. And consumers may not know that acetaminophen is present in many over-the-counter products, including remedies for colds, headaches and fevers, making it possible to exceed the recommended acetaminophen dose.

Despite more than five years of FDA-sponsored consumer education campaigns, "recent studies indicate that unintentional and intentional overdoses leading to severe hepatotoxicity continue to occur," the report said.

The report also calls for limiting the maximum adult daily dose to no more than 3,250 milligrams, but with a lower daily maximum for patients consuming three or more alcoholic drinks every day while using acetaminophen products. It also recommends limiting the tablet strength for immediate-release formulations to a maximum of 325 milligrams, and the single adult dose to a maximum of 650 milligrams.

The recommendations also include:

  • limiting pediatric liquid formulations to one mid-strength concentration (compared to multiple dose strengths available now);
  • requiring that a measuring device (such as a calibrated cup with dosing increments) be included in each package;
  • including dosing
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