Vioxx (Anti-inflammatory Drug) Causes Heart Attacks & Strokes

Pharmaceutical giant Merch, announced in Spetember 2004, the withdrawal of Rofecoxib, more commonily known as Vioxx from the worldwide market. Their reasons were due to safety concerns of increased 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 approved by the American Food and Drug Administration (FDA – similar to Australia’s TGA) in 1999 for the relief of the signs and symptoms of Osteoarthritis. It is also used for acute pain in adults, and for the treatment of menstrual symptoms. It was later apporved for the relief of rheumatoid arthritis in adults and children.

You may recall that Vioxx was championed as a new drug to replace Celebrex. Celebrex was shown to cause damage to the liver and kidneys and bleeding from the bowel.

In a recent study on Vioxx, the Data Safety Monitoring Board recommended it be stopped as it became apparent that the long term use of Vioxx was associated with catastrophic consequences.

The study showed an increased risk of cardiovascular events, including heart attack and stroke, in patients receiving Vioxx compared with placebo, particularly those who had been taking Vioxx for loner than 18 months.

A meeting was held with Merck and FDA officials and based on this new safety information, Merck informed the FDA they would ‘voluntarily’ withdraw Vioxx from the market.

Acting FDA commissioner, Dr. M Crawford states that the FDA will closely monitor other drugs in the class for similar adverse effects. “All of the NSAID’s have risks when taken chronically, expecially of gatrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under strict supervision due to their side effects.”