After three days of hearings, an FDA advisory panel reportedly voted 17-15 to return Vioxx to the market, a closer vote than those for Celebrex and Bextra, which divided panel members 31-1 and 17-13, respectively.
Although the products have been deemed safe enough to remain on the market, suggestions for restrictions include black box warnings advising patients of the heart safety risks, and suggestions that the COX-2 inhibitors only be prescribed after other treatments have failed.
If the FDA follows the recommendations of the panel, which, it seems, is usually the case, Merck in particular would benefit by gaining added legal standing with regards to the numerous court cases filed by patients who had taken Vioxx prior to the drug’s withdrawal in September.
Vioxx’ return to market could, however, signal bad tidings for a number of other firms, including Pfizer, which have benefited since Merck’s voluntary withdrawal of the drug left a $2.5 billion gap in the COX-2s market.