FDA Orders Review of Celebrex® and BEXTRA® Studies

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Federal regulators ordered reviews of numerous ongoing patient studies of the prescription painkillers Celebrex® and Bextra® in light of recent findings that both drugs may increase the risk of heart attack and stroke.

The advisory from the FDA also urges physicians to be highly selective in writing prescriptions for Celebrex® and Bextra®. Patients at risk of stomach bleeding and those with a history of intolerance or who have not shown progress with other pain medications "may be appropriate candidates" for the drugs, said Dr. John Jenkins, director of the FDA's Office of New Drugs.

Jenkins said the FDA may take other actions on Cox-2 inhibitors, and on naproxen, the active ingredient in nonprescription painkillers such as Aleve®, which one study has linked to heart problems. "We think we need to take time to do a careful review so that we can make appropriate regulatory decisions," he said.

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