FDA Orders New Vioxx LabelingApr 11, 2002 | AP
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Doctors reading the label of the popular arthritis drug Vioxx will now learn it may be linked to high blood pressure and a small but troubling increase in the risk of heart attacks.
The Food and Drug Administration ordered new precautions onto Vioxx's label Thursday, advising that doctors consider the risk when prescribing the drug to patients with a history of heart disease.
Manufacturer Merck & Co. got good news, too: Vioxx can advertise that it's gentler to the stomach than an older competitor â€” and that it relieves the pain of rheumatoid arthritis in addition to the more common osteoarthritis.
Vioxx and another popular competitor, Celebrex, work differently than older, cheaper painkillers known to cause stomach ulcers. Merck had fought for over a year to be allowed to say Vioxx is gentler to the stomach. Thursday, the FDA agreed that an 8,000-patient study found Vioxx users had half the risk of ulcers as users of the older naproxen.
The same study found Vioxx users had twice the risk of heart attacks or other cardiovascular side effects than naproxen patients. Merck argued that Vioxx isn't bad, but that naproxen offered the added benefit of thinning the blood a little, which Vioxx doesn't do. Two studies comparing Vioxx to a dummy pill found no difference in risk of heart attack.
No one knows yet if there's a real problem, but "it is an area of concern" that is "important enough to raise a flag for doctors to think about," said Dr. Lawrence Goldkind, FDA's chief of anti-inflammatory drugs.
Studies also show Vioxx can increase the risk of high blood pressure, and that people who use higher-than-recommended doses are more at risk for certain side effects, Goldkind added. Many people chronically use a 50-milligram dose of Vioxx, twice the amount FDA recommends.
The consumer message: "There is a balance you have to weigh between the risks of one (drug) and the other," Goldkind said.