VIOXX®: HEART ATTACKS, STROKES AND OTHER SIDE EFFECTS

Vioxx® was approved by the Federal Drug Administration oi November 2001 and went to market in March 2002. Vioxx® is made by Merck.
Vioxx is prescribed for the relief of symptoms of:

• osteoarthritis
• adult rheumatoid arthritis
• severe menstrual cramping

Essentially, non-steroidal anti-inflammatory drugs (NSAIDs) are increased-strength painkillers designed to treat severe, chronic pain, such as that associated with osteoarthritis, rheumatoid arthritis, menstrual cramps, and other ailments. Many such NSAIDs, including Vioxx®, have been determined to cause serious side effects, ranging from stomach bleeding, stomach ulcers, intestinal bleeding, heart complications, and even death. However, Vioxx® (and its competitors Celebrex® and Bextra®) claimed to successfully treat pain without such drawbacks. But as a recent study put forth by Merck & Co attests, this just isn’t the case. In fact, Vioxx® users are believed to be twice as likely as nonusers to suffer strokes, heart attacks, and blood clots and are still susceptible to other health ailments, ranging from kidney damages to hypertension.

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.

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 last year 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.