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FDA Proposal for Painkiller Warning Is Decades Late

Dec. 19, 2006

FDA Proposal for Painkiller Warning Is Decades Late

Statement of Dr. Peter Lurie, Deputy Director of Public Citizen’s Health Research Group

Finally, the Food and Drug Administration (FDA) is proposing to put labels on over-the-counter pain relievers warning of the potential for stomach bleeding and liver damage.

Our major question is: What took the agency so long?

In 1977, the FDA’s Advisory Review Panel recommended the following warnings for acetaminophen-containing products: “Do not exceed recommended dosage because severe liver damage may occur” and “Do not exceed recommended dosage or take for more than 10 days, because severe liver damage may occur.” For almost three decades, the FDA chose to ignore this wise advice.

In 2002, we presented testimony to the FDA’s Nonprescription Drugs Advisory Committee showing that the National Hospital Discharge Survey (NHDS) indicated an average of 26,256 hospitalizations and 458 deaths per year related to acetaminophen overdoses. More than half of these overdoses were intentional (mostly suicides), but, at the behest of Tylenol maker Johnson & Johnson, many measures to prevent intentional overdose were removed from the debate at the 2002 advisory committee meeting, and now from the FDA’s proposed solution to the problem. In particular, the number of acetaminophen pills per package should be limited and the number of milligrams per pill should be reduced, as has been done in Great Britain, where some studies show reductions in liver transplants and deaths as a consequence.

In February 2006, we posted on our Web site, www.WorstPills.org, information about research showing that the percentage of all U.S. cases of potentially fatal acute liver failure that were associated with the use of acetaminophen rose from 28 percent in 1998 to 51 percent in 2003.

The FDA’s new warning on nonsteroidal anti-inflammatory drugs such as aspirin, ibuprofen and naproxen is also based on evidence available for decades and recommended by the Nonprescription Drugs Advisory Committee in 2002.

In addition to requiring labels, the FDA should require that advertisements for these pain medications include the warnings, and the agency should make public service announcements to educate the public. The FDA needs to make up for lost time.