Painkillers’ benefits, health risks weighed at special FDA hearing
Washington ? Vioxx, the prescription painkiller implicated in the deaths of thousands of Americans and withdrawn from sale in September, may be reintroduced in the market if the Food and Drug Administration concludes the benefits of the drug outweigh its hazards, an executive for Merck & Co. said Thursday.
Dr. Peter Kim, head of Merck Research Laboratories, made the comments at a special FDA hearing called to assess the risks of Cox-2 inhibitors — the family of painkillers that includes Vioxx.
“If the advisory committee and the FDA conclude that the benefits of the class outweigh the risk in some patient populations, then we would have to consider the implications of these new data, given the unique benefits Vioxx offers,” he said.
Kim said his company had heard from patients who said Vioxx was the only medication that alleviated their pain. He also said a newly released study suggested the hazards and benefits of Vioxx are similar to those for Celebrex and Bextra, two other painkillers in its class that remain on the market.
Dr. Alastair Wood, who’s chairing the FDA hearings, said afterward that any reintroduction of Vioxx “would be an amazing outcome.”
Merck took Vioxx off the market after a study found that patients taking the drug for at least 18 months had twice the risk of cardiovascular disease compared with people not taking the drug.
Studies also have shown that Celebrex and Bextra, made by Pfizer and currently still being sold, may pose an additional risk, although the hazards appear to be less than those of Vioxx.
Meanwhile, the senior safety expert for the FDA who first estimated that Vioxx was killing tens of thousands of Americans warned Thursday that other commonly used pain medications also are risky.
Dr. David Graham, an FDA epidemiologist, told the panel of medical experts that studies suggest an older generation of drugs taken for pain and inflammation, such as ibuprofen and indomethacin, also may increase the risks of heart attacks and strokes.
While Graham said preliminary findings suggested the risks of the older drugs were far less than those of Vioxx, he said more studies should be conducted.




