Worldwide drug withdrawal puts FDA under scrutiny Merck faces 300 lawsuits Karen

Vioxx is a cyclooxygenase (COX)-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by the USA’s Food and Drug Administration (FDA) in May 1999 for the relief of the signs and symptoms of osteoarthritis, the management of acute pain in adults, and the treatment of menstrual symptoms. Vioxx was later also approved for the relief of signs and symptoms of rheumatoid arthritis in adults and children. Vioxx was the second of a new kind of NSAID (Cox2 selective) approved by FDA. Other similar drugs in this class include Bextra and Celebrex. At the time that Vioxx and other Cox-2selective NSAIDs were approved, it was hoped that they would have a lower risk of gastrointestinal ulcers and bleeding than other traditional painkillers such as aspirin, ibuprofen or naproxen. Vioxx is the only NSAID demonstrated to have a lower rate of these side effects. Worldwide sales of Vioxx last year reached US$2.5 billion, following the most impressive sales growth for any drug in 2001. Further Laboratory and pharmaceutical news page 13 Worldwide drug withdrawal puts FDA under scrutiny Merck faces 300 lawsuits Karen Dente reports from the USA