Arcoxia, Merck’s latest in its line of Cox-2 inhibitors, has received a non-approval letter from the FDA. Currently on the market in 63 countries, Arcoxia has been marketed for arthritis relief and currently contributes roughly $265 million a year in sales for Merck. The FDA has said that in order for Arcoxia to be approved in the United States, Merck “needs to provide more test results showing that Arcoxia’s benefits outweigh its risks before it has another chance of getting approved.” This decision comes as no surprise after a FDA expert panel announced in April that they had voted 20-1 against approving the drug.
Vioxx and its counterpart Bextra, members of the NSAID family along with Aleve, were pulled from the shelves in 2004 and 2005, respectively, after it was concluded that taking these medications significantly increased one’s risk for heart attack and stroke. The FDA has stated that any nonsteroidal anti-inflammatory drugs (NSAIDS) will be approved only if they meet an unfulfilled need for patients with no other safer options at their disposal.