Bayer AG (BAYN)’s Aleve may put patients at less risk of heart attacks and strokes than similar pain-relief medicines, U.S. regulatory workers said in a report.
The Food and Drug Administration is asking advisers to weigh whether an ongoing safety study of Pfizer Inc. (PFE)’s arthritis medicine Celebrex compared with ibuprofen and naproxen, the main ingredient in Aleve, should stop since naproxen is seen as safer. Celebrex was New York-based Pfizer’s fourth best-selling drug last year with an estimated $2.7 billion in sales, according to data compiled by Bloomberg.
An analysis published in the medical journal Lancet in May showed naproxen had a lower heart risk than other painkillers. The FDA wants advisers to weigh in on whether accumulated data make the same point and if that has any implications for the safety study, doctors and patients.
“It is generally considered unreasonable from the standpoint of subject welfare to randomize subjects if one of the treatments has been shown to be safer with respect to serious or fatal outcomes,” FDA staff wrote in a report today.
A panel of advisers will meet starting Feb. 10 to discuss heart risks associated with the pain relievers known as non-steroidal anti-inflammatory drugs, or NSAIDs.
The FDA in 2005 asked NSAID manufacturers to change their labels to reflect the potential for increased cardiovascular risk after Merck & Co. withdrew Vioxx over safety concerns. The FDA now is weighing whether the over-the-counter status of some NSAIDs should change. Pfizer’s Advil and Johnson & Johnson (JNJ)’s Motrin are NSAIDs sold without a prescription.
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