FDA Approves Vioxx for Treatment of Rheumatoid Arthritis

The Food and Drug Administration has given supplemental approval for use of Vioxx, already approved for treatment of arthritis, to be used in treatment of rheumatoid arthritis.

The FDA also approved label changes that enable Vioxx to advertise that it is gentler on the stomach than traditional medicines, but also that it may increase the risk of heart attack or cause high blood pressure.

In a prospective one-year study, researchers evaluated approximately 8,000 patients who received 50 milligrams of Vioxx daily (twice the highest approved dose for chronic use), or the standard dose of naproxen.

Results from the randomized, double-blind study showed that Vioxx was more than 50 percent gentler on the stomach than naproxen.

Results, however, also showed that compared to naproxen, Vioxx was associated with a 50 percent greater risk of heart attack, prompting the FDA to advise doctors to use caution with patients who have heart disease.

Data from two smaller studies, comparing 25 milligrams daily of Vioxx with a placebo, did not show an increased risk of heart attack.

Researchers also found that chronic rheumatoid arthritis patients who received 25 milligrams of Vioxx were at a greater risk for developing high blood pressure.

Other sources: FDA