To: Little Gorilla who wrote (7469 ) 4/20/1999 8:38:00 PM From: BigKNY3 Read Replies (1) | Respond to of 9523
Little Gorilla: No surprises with the Vioxx Advisory Panel. BigKNY3 FDA Panel Recommends Painkiller OK 04/20/1999 AP Online WASHINGTON (AP) - Government advisers recommended approval Tuesday of a powerful and potentially safer painkiller, Merck & Co.'s Vioxx, which promises competition for one of the nation's biggest-selling drugs. Advisers to the Food and Drug Administration voted Tuesday that Vioxx effectively treats osteoarthritis pain and that it is an effective analgesic for acute pain like that caused by dental work and certain surgeries. Vioxx has been trumpeted as a new type of drug that relieves aches and inflammation with fewer stomach-damaging side effects. Millions of people now depend on aspirin, ibuprofen, naproxen and a host of other pills called "non-steroidal anti-inflammatory drugs," or NSAIDs, to relieve pain. But NSAIDs can cause ulcers, stomach bleeding and other gastrointestinal side effects, especially in long-term users. They are blamed for causing 107,000 hospitalizations every year, and for killing 16,500. The reason: NSAIDS target an enzyme called cyclo-oxegenase that is responsible for much inflammation. But there are two types of this enzyme. Cox-2 is believed to cause inflammation, while Cox-1 protects the stomach lining. NSAIDs hit both. So scientists developed more specific drugs to target just Cox-2. The first Cox-2 inhibitor to hit the market was Monsanto's Celebrex , for arthritis pain. Doctors have written more than 2 million prescriptions in its first three months of sale. Vioxx promises stiff competition, particularly as FDA's advisers on Tuesday said the drug was proven to treat both arthritis pain and pain from other causes. However, the advisory panel wasn't convinced that Merck had proved that, over the long term, Vioxx will cause fewer problematic ulcers. It decided the drug must bear the same ulcer warning as NSAIDs - and Celebrex - do, although Vioxx's label can include reports of studies that suggest the risk will turn out to be lower. The FDA isn't bound by its advisers' recommendations, but typically follows them.