Vioxx : Heart Attacks and Other Side Effects

09/30/2004: VIOXX RECALLED WORLDWIDE

Vioxx, also known as rofecoxib, was approved by the FDA on November 2001 and went to market in March 2002. Vioxx is made by Merck.

Vioxx is prescribed for the relief of symptoms of:

• osteoarthritis (also known as "wear and tear" arthritis, a degenerative joint disease common in older people)
• adult rheumatoid arthritis (a severe form of arthritis which affects over 2 million people)
• primary dysmennorhea (severe menstrual cramping)

Vioxx Side Effects

The European Medicines Evaluation Agency (EMEA) has issued a warning alerting patients of serious side effects associated with rofecoxib (Vioxx).

In November 2002, the U.S. Food and Drug Administration (FDA) issued a warning about Vioxx. The FDA has received about 20 reports of serious reactions among Vioxx users since sales began. The FDA also mandated product label changes for Vioxx. Merck, the manufacturer of Vioxx, sent letters to thousands of physicians alerting them to the new warnings.

A large study sponsored by Merck showed that patients taking Vioxx had four times the risk of heart attacks and that the risk appears to increase over time. Doctors are worried about the possibility of heart attacks because many of the arthritis patients taking Vioxx are elderly and have a higher risk of cardiovascular problems to begin with. While Vioxx does seem to cause fewer serious ulcers, FDA medical officers say the potential safety advantage is being offset by a higher risk of heart problems due to an excess of serious cardiovascular events.

In a study of more than 8,000 patients that compared the COX-2 inhibitor rofecoxib (Vioxx) with the traditional NSAID naproxen, the risk of cardiovascular problems, including heart attack, chest pain related to heart disease, stroke, sudden death and blood clots, was more than two times higher in the rofecoxib group than in the naproxen group.

Vioxx and Heart Attacks

Recent studies have shown that Vioxx can increase the incidence of heart attack nearly four times greater than that of traditional arthritis pain relievers like NSAIDS. More specifically, the new study out of the Cleveland Clinic noted an increase in the development of myocardial infarctions, or heart attacks, in people treated with Vioxx, when compared with those treated with naproxen (a standard NSAID). While the risk of heart attack is still low, it is a concern for those users who may have had cardiac problems in the past.