The National Cancer Institute Discovers Problems with Celebrex

The National Cancer Institute (NCI) has stopped the administration of Celebrex (celecoxib) in their ongoing clinical trial. The NCI was investigating the use of the drug for preventing colon polyps. The clinical trial involved three groups of patients. One group was administered 400 mg of Celebrex twice daily, one group was administered 200 mg of Celebrex twice daily, and a third group was administered a placebo. The average duration in the trail was 33 months.

It was discovered that patients taking 400 mg of Celebrex twice daily had a 3.4 times greater risk of cardiovascular (CV) events compared to the placebo group. And, the patients taking 200 mg of Celebrex twice daily had a 2.5 times greater risk of CV events compared to the placebo group. However, a similar ongoing clinical study comparing a patient group receiving 400 mg of Celebrex once daily with a placebo group has not shown a greater risk for CV events than those taking the placebo.

The FDA has reviewed preliminary clinical study results and will perform a thorough investigation of the data from this and similar studies to determine appropriate regulatory action. The findings are similar to recent results from a Vioxx (rofecoxib) study, which is in the same drug class as Celebrex. An additional drug called Bextra (valdecoxib), has also shown an increase in cardiovascular events in patients after undergoing heart surgery. Bextra and Celebrex are currently the only two selective COX-2 agents on the U.S. market.

Celebrex was approved in 1998 for treating osteoarthritis and rheumatoid arthritis. The findings of the clinical studies performed at that time did not suggest the CV risks that were found in the NCI polyp studies. However, the FDA has advised physicians to use a "risk-benefit analysis" on a patient-by-patient basis when determining if Celebrex should be administered. If physicians determine the benefits outweigh the risks for a particular patient, the FDA advises a reduction in prescription dose to the lowest effective dose.