Pharmaceutical giant Merch, announced in Spetember2004, the withdrawal of Rofecoxib, more commonily known as Vioxx fromthe worldwide market. Their reasons were due to safety concerns ofincreased risk of heart attack for those using the drug.
Vioxx is a cyclo-oxygenase 2-selective, nonsteroidal,anti-inflammatory dug (otherwise know as a 'NSAID's”) that was approvedby the American Food and Drug Administration (FDA – similar toAustralia's TGA) in 1999 for the relief of the signs and symptoms ofOsteoarthritis. It is also used for acute pain in adults, and for thetreatment of menstrual symptoms. It was later apporved for the reliefof rheumatoid arthritis in adults and children.
You may recall that Vioxx was championed as a new drug to replaceCelebrex. Celebrex was shown to cause damage to the liver and kidneysand bleeding from the bowel.
Ina recent study on Vioxx, the Data Safety Monitoring Board recommendedit be stopped as it became apparent that the long term use of Vioxx wasassociated with catastrophic consequences.
The study showed an increased risk of cardiovascular events,including heart attack and stroke, in patients receiving Vioxx comparedwith placebo, particularly those who had been taking Vioxx for lonerthan 18 months.
A meeting was held with Merck and FDA officials and based on thisnew safety information, Merck informed the FDA they would 'voluntarily'withdraw Vioxx from the market.
Acting FDA commissioner, Dr. M Crawford states that the FDA willclosely monitor other drugs in the class for similar adverse effects.”All of the NSAID's have risks when taken chronically, expecially ofgatrointestinal bleeding, but also liver and kidney toxicity. Theyshould only be used continuously under strict supervision due to theirside effects.”