Scientists Advise On New Drug Vioxx

February 9, 2001
WASHINGTON (AP) - The arthritis drug Vioxx appears to cause fewer ulcers than the older painkiller naproxen and its label should say so, the government's scientific advisers decided Thursday in a boon for maker Merck & Co.

But the panel didn't have all good news for Merck: Vioxx should retain its strong warning that it can cause ulcers just like some other older, cheaper painkillers - and doctors and patients should be warned that it might carry a heart risk, too.

The recommendation comes as Vioxx and competitor Celebrex, two popular arthritis painkillers, jockey for sales.

Merck and Celebrex maker Pharmacia Corp. want the Food and Drug
Administration to quit making the products bear the same warning as older painkillers that users risk developing ulcers, even life-threatening gastrointestinal bleeding. Celebrex and Vioxx work slightly differently than older painkillers, and thus proponents hoped they would prove gentler on the stomach. But on Wednesday, the same FDA advisory panel ruled there's no proof Celebrex is gentler on the stomach.

Then Thursday, the panel examined Merck's 8,000-patient study comparing Vioxx and naproxen - and said Vioxx did cause somewhat fewer ulcers. But the panel said the drug's label should reflect both that one study and retain its broad warning that Vioxx still can cause ulcers.

Also, the panel said patients and doctors must be warned that in the study, Vioxx patients had twice the risk of heart attacks or other cardiovascular side effects as naproxen users.

Why? No one's sure. Partly, naproxen may thin the blood, much like the aspirin used by heart patients to prevent blood clots, and thus using Vioxx instead deprived patients of the other drug's side benefit. However, some critics say Vioxx and Celebrex themselves may increase the risk of blood clots. FDA's advisers concluded more research is needed but that meanwhile, Vioxx's label should warn of the concern.

The FDA isn't bound by its advisers' recommendations but typically follows them.

Copyright 2001 The Associated Press. All rights reserved.

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