CELEBREX

Celebrex is a drug used to prevent colon cancer in high-risk patients and treat arthritis. However, researchers warn that the drug can also increase your risk of suffering a stroke or heart attack. Pfizer Inc. claims that high doses of the drug may lower pre-cancerous polyps by up to 45%, based on two clinical trials. Unfortunately, an analysis of these same studies revealed that patients who took Celebrex also suffered more cardiovascular complications.
Celebrex is a COX-2 inhibitor which works in much the same way as Merck & Co. Inc.’s Vioxx. This drug was removed from the market in 2004 after studies revealed that it doubled the risk of strokes and heart attacks. During the American Association for Cancer Research’s annual meeting, participants evaluated the possibility that over-expression of the COX-2 enzyme contributes to the spread and growth of colorectal tumors. If this is the case, COX-2 inhibitors may lower the amount of benign tumors in patients with a history of the disease and hinder development of sporadic colorectal tumors.
The trials involved patients who were on average 60 years old and had previously had precancerous colon polyps removed. Most of the participants were smokers who had several cardiovascular risk factors, including chest pain, diabetes, high blood pressure and previous strokes or heart attacks.
Pfizer and the National Cancer Institute co-sponsored the APC trial, whereas Pfizer was the only sponsor of the PreSAP trial. The end results of the APC trial confirmed earlier results released in 2004; a significantly higher percentage of trial participants who took Celebrex showed higher risk of serious cardiovascular problems than patients who took a placebo.
Pfizer claims that the PreSAP trial’s preliminary results did not reveal an increase in cardiovascular problems. However, the company also admitted that a broader analysis of cardiovascular problems such as chest pain revealed more cardiovascular problems for patients taking Celebrex than ones who took the placebo. Pfizer indicated that these results are consistent with the Celebrex label’s warnings regarding cardiovascular risk.
The drug manufacturer stated that it has disclosed information about the PreSAP and APC trials to worldwide regulatory agencies. Pfizer also stated that it will submit the final reports to the American Food and Drug Administration (FDA), as well as other regulatory agencies.