FDA Orders New Vioxx Labeling

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FDA Orders New Vioxx Labeling

Thu Apr 11, 6:03 PM ET

WASHINGTON - 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 (news - web sites) 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 — 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.