Message Mixed From Celebrex

In 2004, preliminary results for the cosponsored study revealed "a statistically significant increase" in cardiovascular risk among people taking Celebrex compared with those getting a placebo, Pfizer said. The other test didn't show a statistically significant difference.

"A new broader analysis of serious and other cardiovascular events [for both studies] found more cardiovascular events with Celebrex compared to placebo," Pfizer said Monday. "These results are consistent with the current warnings on cardiovascular risk with the Celebrex label."

Pfizer also is undertaking a Celebrex cardiovascular risk study of 20,000 patients worldwide, led by the Cleveland Clinic. The study will take 18 months, and patients will be followed for two years. It will track heart attacks, strokes and deaths among patients taking Celebrex and two older, now-generic drugs, naproxen and ibuprofen. Naproxen is best known as prescription-strength Naprosyn or over-the-counter Aleve. Ibuprofen is best known as Motrin.

The controversy over COX-2 drugs caused a big drop in Celebrex sales to $1.73 billion last year vs. $3.3 billion in 2004. Bextra had $1.29 billion in sales in 2004, but the cost of suspending the drug led to a loss of $61 million last year.

Celebrex has been approved by the FDA for many uses, the most notable being osteoarthritis, rheumatoid arthritis, a form of arthritis called ankylosing spondylitis, acute pain and menstrual cramps.

The drug also is approved for patients with familiar adenomatous polyposis, or FAP, a rare genetic disease that causes the rapid development of colon polyps. FAP patients have a high risk of colon cancer.

The latest studies looked at how Celebrex affects the development of sporadic precancerous tumors in the colon. Both tests were scheduled to run 36 months, but patients stopped receiving Celebrex after 33 months when the high rate of cardiovascular risk was detected in the National Cancer Institute-Pfizer test.