Fast Facts on Bextra and Celebrex
April 7, 2005 — -- The Food and Drug Administration asked Pfizer Inc. to pull the painkiller Bextra off the shelves today in a voluntary recall after considering data that the drug poses higher-than-normal cardiovascular risk and potentially life-threatening skin reactions.
The FDA also requested that drug makers include a boxed warning in the label for drugs in the same class of non-steroidal anti-inflammatory drugs, including Celebrex.
The following are some facts on the once-popular medications.
Bextra is the name Pfizer gave to valdecoxib, a non-steroidal anti-inflammatory drug developed by the company. It was approved by the FDA in 1999 as a treatment for pain from osteoarthritis, adult rheumatoid arthritis and menstrual cycles.
Celebrex is the commercial name for celecoxib, another NSAID developed by Pfizer, which was approved by the FDA in 1998 as treatment for osteoarthritis and adult rheumatoid arthritis.
Bextra and Celebrex are classified as COX-2 inhibitors, a type of drug that selectively inhibits COX-2, an enzyme involved in inflammation, while sparing COX-1, thereby reducing toxicity in the digestive tract.
The FDA concluded that the overall risk outweighed benefits for patients taking Bextra, while benefits outweigh potential risks for properly informed patients taking Celebrex.
The FDA has been focusing on the safety of COX-2 inhibitors since Merck & Co. voluntarily pulled Vioxx from the market on Sept. 30 after some users reported heart problems. The painkillers were once particularly popular among arthritis sufferers.
Twelve percent of adults in the United States (about 25 million people) reported taking prescription drugs for arthritis, according to a July 2000 Kaiser poll.
Sales of Celebrex reached $3.3 billion last year while Bextra sales were $1.3 billion. But sales of both drugs have slowed since the Vioxx withdrawal raised safety questions about the entire class of drugs.
Advertising to consumers and physicians helped fuel the growth of COX-2 inhibitors. In 2002, Merck spent $171 million to promote Vioxx to physicians, while Pfizer spent $133 million on Celebrex and another $120 million on Bextra.
Total U.S. sales of COX-2 inhibitors (including Vioxx and Celebrex) was $4.5 billion in 2003.
A Canadian study from May 2004 investigated the safety of COX-2 inhibitors. Patients in the study using Vioxx had an 80 percent increased risk of hospital admission for congestive heart failure compared to those taking Celebrex.
A 1999 clinical trial conducted by Pfizer found that elderly patients taking Celebrex were more likely to suffer heart problems than patients taking a placebo. Pfizer has claimed the study was flawed.
Sources: Pfizer, Inc., www.fda.gov, British Medical Journal, Cleveland Clinic Journal of Medicine, ABC News Medical Unit