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FDA Panel Urges Tough Controls on Acetaminophen Painkillers
Date:6/30/2009

hen combination products," Kweder said. "If we don't eliminate these combination products we should certainly at least lower the usual acetaminophen dose patients receive in those prescription combination products," she said.

At the very least the agency should require new warning labels on these prescription combinations that alert patients to the potential of liver damage if they take too much acetaminophen, she said.

Despite more than five years of FDA-sponsored consumer education campaigns, "recent studies indicate that unintentional and intentional overdoses leading to severe hepatotoxicity [liver damage] continue to occur," last month's report noted.

Speaking for the OTC drug industry, Lynda A. Suydam, of the Consumer Healthcare Products Association (CHPA) said the group is "pleased the committee did not recommend eliminating these important nonprescription products."

However, in a statement, she said CHPA was "disappointed in [the panel's] divided vote to lower the maximum daily dose and the single dose of 1000 mg acetaminophen. There was a notable lack of data referenced by the committee to support these recommendations and overwhelmingly strong data affirming the efficacy and safety of acetaminophen in its current dosage forms."

Another expert took a different view. Dr. John H. Klippel, chief executive officer of the Arthritis Foundation, said Tuesday's votes were very important to "people with arthritis because acetaminophen is a very commonly used medication to control pain."

"Lowering the maximum dose, providing that kind of guidance to patients, if it increases safety, would be something the arthritis community would support," he said. "Every person who takes this drug sees it as valuable, but they want clear guidance so they won't be harmed by the drug."

Dr. Lewis W. Teperman, director of transplant surgery and vice chairman of surgery at New York University School of Medicine, sai
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