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.”
Research in mice suggests that a newer class of painkilling drugs called COX-2 inhibitors could trigger a chain of events potentially harmful to the cardiovascular system. Researchers speculate, though, that their findings might explain the outcome of a recent major trial in which patients taking a COX-2 inhibitor – the arthritis drug Vioxx – had […]
It seemed like a good idea at the time: drugs that selectively inhibited cyclooxygenase 2 (COX-2) would inhibit the synthesis of prostaglandins responsible for pain and inflammation, without interfering with the important “housekeeping” function of COX-1, such as maintenance of gastric mucosal integrity. It soon became apparent, however, that the COX-2 inhibitors (led by Celecoxib […]
The online version of the Lancet has published a study that says that the arthritis drug Vioxx could have caused up to 140,000 cases of coronary heart disease in the US since it was launched in 1999.
The US Food and Drug Administration study analysed data from 1.4 million people in California who had used either Vioxx, Celecoxib (Celebrex) which is from the same group of drugs, or other non-steroidal anti-inflammatory drugs (NSAID’s) between 1999 and September last year. 40,000 had used Celecoxib, just under a million had used ibuprofen, 435,000 naproxen and 27,000 Vioxx.