Celebrex® May Increase the Risk of Heart Attacks and Strokes
WASHINGTON, DC -- December 21, 2004 -- The arthritis drug, Celebrex® (celecoxib), may increase the risk of heart attacks, strokes, and heart-related deaths, the Food and Drug Administration (FDA) warned last Friday. The alert was based on a study of 2,000 patients with colorectal cancer. Those patients who took Celebrex® had a much greater chance of developing serious heart problems than did those who took fake pills or placebos.
Known as the Adenoma Prevention with Celecoxib clinical trial, the study was sponsored by the US National Institute of Health (NIH) and Pfizer, Celebrex®'s manufacturer. The agency halted the trial when it found that the risk of heart problems was 2.5 times greater in patients taking 400 milligram of Celebrex® daily than it was for those who did not take the drug.The risk was 3.4 times higher for patients who received 800 milligrams per day compared with patients who took placebos (National Cancer Institute Press Release, December 17, 2004).
Pfizer Will Pull Celebrex® Ads
The FDA declined to comment about whether it will withdraw Celebrex® from the market, but noted that "we do have great concerns about this product and this class of products" (Acting FDA Commissioner Lester Crawford, Wall Street Journal, December 20, 2004). The agency asked Pfizer to pull its advertisements for Celebrex® from television, radio, magazines, and newspapers.
Although Pfizer said it will temporarily remove the Celebrex® ads, the company will continue to sell the drug. It also agreed to inform doctors prescribing Celebrex® that they should consider alternative treatments for patients (FDA Press Release, December 20, 2004).
Celebrex®, Bextra®, and Vioxx®: COX-2 Inhibitors That May Cause Heart Problems
Celebrex® is used to relieve the symptoms of osteoarthritis and rheumatoid arthritis, to treat painful menstrual periods, and to reduce pain after surgery. It may also help reduce growths or polyps in the colon of patients with a disease called Familial Adenomatous Polyposis, an inherited condition in which the colon becomes covered with many polyps.
Celebrex® is related to the arthritis drug Vioxx® (rofecoxib), which was withdrawn from the market in September, because it increases the risk of heart attacks, strokes, and vascular disease. Vioxx® was manufactured by Merck. Both Celebrex® and Vioxx® are nonsteroidal anti-inflammatory drugs (NSAIDs) that block cyclooxygenase, an enzyme needed for the production of prostaglandins. Prostaglandins may cause inflammation and pain. Celebrex® and Vioxx® interfere with the form of cyclooxygenase known as COX-2, and are therefore referred to as COX-2 inhibitors.
Besides producing Celebrex®, Pfizer manufactures another arthritis drug and COX-2 inhibitor, Bextra® (valdecoxib). A recent warning on the Bextra® label states that patients who have undergone heart bypass surgery should not take the drug because it increases their risk of additional heart problems. Bextra® may also cause a severe allergic skin reaction known as Stevens-Johnson syndrome in some users. See Bextra® Label Updated for more information.
COX-2 Inhibitors Are Blockbuster Moneymakers
Last year, Celebrex® sales totaled almost $2 billion. In the month after Vioxx® was recalled, Celebrex® accounted for 63.5% of the market for COX-2 inhibitors, or $260 million; while Bextra® sales were 36% of that market or $148 million (USA Today, November 30, 2004). Clearly, Celebrex® and Bextra® are money-making blockbuster drugs, and Pfizer has a lot to lose if their sales slow down.
Consumer groups, doctors, and some legislators have accused the FDA of working too closely with drug manufacturers and minimizing public safety issues. Medical journal reports suggest that the FDA suppressed knowledge about the risks of Vioxx® and other COX-2 inhibitors. In response to this criticism, and now to newly publicized information about Celebrex®, the FDA will hold hearings on the safety of COX-2 inhibitors early in 2005.
Brayton Purcell is currently reviewing cases involving Celebrex® users who have suffered from heart attacks and strokes. If you or a loved one has had these conditions while taking Celebrex® or after discontinuing the medication, please contact us to learn about your legal choices.