FDA Acetaminophen Warning Labeling Took 29 Years

Twenty-nine years after its own experts first made the recommendation, The Food and Drug Administration (FDA) has proposed new federal regulations requiring that labels on over-the-counter pain relievers containing acetaminophen warn consumers of potential bleeding and liver damage resulting from misuse of the drugs.

At a meeting held on Sept. 19, 2002, the FDA's Nonprescription Drugs Advisory Committee noted, "The Agency is in the process of writing a final regulation for internal analgesic drug products in the OTC drug review. This process began in 1977 with publication of the expert panel report and continued in 1988 with publication of the tentative final monograph. As part of the continuing review of this monograph, it is important to look at recent data pertinent to several safety issues that have been discussed in previous federal register notices."

The end of that very-long regulatory process finally came into view yesterday, when the FDA officially proposed requiring that labels on over-the-counter pain relievers contain "warnings which would highlight the potential for liver toxicity, particularly when using acetaminophen in high doses, when taking more than one product with acetaminophen, and when taken with moderate amounts of alcohol."

The proposed regulations will be published in the Dec. 26, 2006 edition of the Federal Register. A period of public comment will be allowed and, maybe by this time next year -- 30 years after the process began -- the safety labeling regulation will take effect.

As the FDA points out, several makers of over-the-counter pain killers have already voluntarily added labels to their products warning of the dangers identified by the FDA.

The FDA is a regulatory agency of the U.S. Department of Health and Human Services, a Cabinet-level agency.

Also See:
2002 - FDA Warns of OTC Pain Relief Use
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