FDA Panel Votes To Let Merck & Co., Inc.'s (MRK) Vioxx Sales Resume; Panel Says Pfizer Inc.'s (PFE) Celebrex And Bextra To Remain On Market
10/19/2005 5:12:47 PM
A U.S. Food and Drug Administration advisory panel narrowly agreed Friday that Merck's recalled drug Vioxx was safe enough to be sold, and cleared the way for Pfizer's Celebrex and Bextra to remain on the market. The 17-15 ruling paves the way for Merck (MRK: news, chart, profile) to bring the controversial painkiller back to pharmacies. On Thursday, the company said it is considering a comeback for the drug, which was pulled from the market in September over concerns of heart risk.
The matter still must get a final OK from the FDA, but the agency generally always heeds the recommendations of its expert panels.
The news sent Merck shares skyward by $3.76, or 13 percent, to $32.61 at the close. A company spokeswoman said Merck would not comment on the vote.
Meeting for three days on whether Vioxx and other so-called Cox-2 inhibitors should be on the market, panelists also voted 31-1 to keep Pfizer's Celebrex -- also in the same class of drugs -- on the market.
Voting was tighter on Bextra, 17-13 in favor of keeping it on the market. The news sent shares of Pfizer (PFE: news, chart, profile) higher by $1.74, or 6.9 percent, to $26.80.
All three drugs, though, were determined to cause heart risk by the panel in a unanimous vote. And a majority of panelists indicated they supported warning labels for all three, but did not take a formal vote on that matter.
The warning would disclose risks to patients of possible cardiovascular problems.