Merck & Co, Inc has announced a voluntary withdrawal of Vioxx (rofecoxib) from the worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx. The withdrawal is likely to affect the business prospects of about 40 copycat versions of this blockbuster drug that is currently marketed in India.
The drug, which enjoys Rs 100 crore domestic market was approved by the Drugs Controller General of India on June 26,2000. The inventor's product Vioxx got US FDA approval as a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) in May 1999. The drug prescribed for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms, and was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.