FDA Requires Stronger Label Warnings About Propoxyphene

Pain reliever linked to fatal overdose; agency to study how high doses affect heart
By Andrea Mongler
HealthDay Reporter

TUESDAY, July 7 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) has taken steps to help prevent overdose in patients taking pain medications that contain the opioid propoxyphene, including Darvon and Darvocet, according to a July 7 release issued by the agency.

In light of data linking propoxyphene and fatal overdose, the FDA is now requiring manufacturers of products that contain propoxyphene to strengthen the wording of the label, including the boxed warning, so it emphasizes the potential for overdose. The agency is also requiring manufacturers to provide patients with a medication guide that stresses the importance of using the drugs as directed.

In addition, the FDA will undertake a new study that will address questions about how high doses of propoxyphene affect the heart. The agency will also work with other organizations, including the Centers for Medicare and Medicaid Services and the Veterans Health Administration, to try to determine how often the elderly are prescribed propoxyphene and how its safety profile compares to that of other drugs.

"Physicians need to be aware of the risk of overdose when prescribing these drugs. They should carefully review patient histories and make appropriate treatment decisions based on the warnings and directions stated within the drug's label," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research in Silver Spring, Md., said in a statement. "Prescribers and patients should be aware of propoxyphene's potential risks when used at doses higher than those recommended."

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