FDA Mandates Tougher Warnings for Pain Pills

TUESDAY, July 7 (HealthDay News) -- Concerns about the possibility of fatal overdoses led U.S. health officials Tuesday to take several steps to limit the risk of using pain medications containing propoxyphene, including Darvon and Darvocet.

Manufacturers must strengthen the labels of propoxyphene-containing products by adding boxed warnings that emphasize the potential for overdose and developing medication guides to be given to each person filling or refilling a prescription.

The manufacturers must also conduct a new safety study to assess unanswered questions, such as how propoxyphene affects the heart when taken at higher-than-recommended doses, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, said during a news conference.

The FDA is also working with several health-care organizations to collect additional safety data on these products, Woodcock said, adding that "the data we accumulate could result in additional regulatory action."

Woodcock also announced that the FDA has denied a petition from the consumer advocacy group Public Citizen asking for a phased withdrawal of products containing propoxyphene.

"The reason for the denial is that FDA has determined that propoxyphene is an acceptable option for relief of mild-to-moderate pain when taken as directed," she said. "Moreover, FDA recognizes that other options clinicians might have for pain management come with their own safety concerns."

Propoxyphene-containing products have been linked to fatal overdoses, FDA officials said. Between 1959 and 2005, 91 deaths attributed to an overdose of these products have been recorded in the adverse-events database, said Dr. Gerald Dal Pan, head of the FDA's office of surveillance and epidemiology.

But that database would not necessarily register information on deliberate overdosing, Woodcock said.

Last month, European regulators called for the withdrawal of dextropropoxyphene from the market because people taking the 50-year-old drug have been dying from overdoses.

Dextropropoxyphene, which is called propoxyphene in the United States, is an opioid widely used to treat mild to moderate pain. It was first introduced in the United States in 1957 under the brand name Darvon and is marketed today by a wide number of generic drug makers.

Last week, an FDA advisory panel recommended that the popular prescription painkillers Vicodin and Percocet, which combine acetaminophen with an opiate narcotic, be banned.

Darvocet contains acetaminophen.

More information

The U.S. Food and Drug Administration has more on propoxyphene.

SOURCES: July 7, 2009, teleconference with Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, and Gerald Dal Pan, M.D., director, office of surveillance and epidemiology, U.S. Food and Drug Administration

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