NEWS: 2nd Arthritis Drug Under Scrutiny

[Guest guest]

2nd Arthritis Drug Under Scrutiny

NEW YORK, Oct. 19, 2004

Pfizer Inc. plans a major study to see if its anti-arthritis medication,

Celebrex, increases the risk of heart attack and stroke.

The announcement comes three weeks after Merck & Co. pulled Vioxx, a rival

arthritis medication, from the market because the drug doubled the risk of

heart attack and strokes in patients taking the medication longer than 18

months.

Celebrex and Vioxx are both in a class of drugs called cox-2 inhibitors.

Last week, Pfizer said a study showed that Bextra, another cox-2 inhibitor

it sells, increased the risk of heart attacks in patients that had coronary

bypass operations.

In a related development, a top U.S. Food and Drug Administration official

said new pain relievers in the same class as Vioxx and Celebrex face

increased scrutiny because scientists do not have a full comprehension of

how exactly they work in the body.

Acting FDA deputy commissioner Dr. Janet Woodcock also said the agency would

hold an advisory committee meeting early next year to discuss safety of the

drugs known as cox-2 inhibitors.

" We are far from understanding the complex mechanisms that lead to this

toxicity, " said Woodcock, who was speaking at the American College of

Rheumatology's annual meeting in San .

Woodcock's statements don't bode well for Whitehouse Station, N.J.-based

Merck, which has another cox-2 inhibitor called Arcoxia currently under

review at the FDA. The agency is slated to rule on whether to approve the

drug by Oct. 30.

Woodcock said the FDA will examine the length and size of the safety data

drug companies offer when deciding whether to approve a new cox-2. Analysts

don't believe Merck has enough long-term data to establish that Arcoxia has

a safe cardiovascular profile.

In a statement, Pfizer said that in completed studies and ongoing trials,

Celebrex has proven to be safe and also has shown it could help patients

with cardiovascular disease.

The study, which is expected to begin next year, will enroll more than 4,000

patients around the world.

http://www.cbsnews.com/stories/2004/10/19/health/printable650071.shtml