Celebrex, Bextra recall demanded

Since the recall of Vioxx, there has been a lot of discussion if other Cox-2 drugs like Celebrex and Bextra should be recalled. While the maker of both drugs on the market, Pfizer, has been warned by FDA for misleading ads and has been sued by many plaintiffs who argue that the company did not disclose the adverse side effects of the drugs, the company continues to stand by the safety of the drugs. (Related article: Pfizer sued by Celebrex, Bextra patients)

Not everyone is convinced though. Doctors are asking that Cox-2 drugs not be prescribed in most cases till a more accurate safety profile is developed. The European Medicines Agency (EMEA) has asked Pfizer for more data on the side effects of Celebrex and Bextra. Pfizer's argument about the safety of Celebrex and Bextra has not been found to be convincing when researchers from the University of Chicago and Stanford University School of Medicine found that most of the growth in COX-2 use between 1999 and 2002 occurred in patients at little risk for side effects from the drugs COX-2s were developed to replace. They found that:

• Vioxx was more expensive than over-the-counter pills but no more effective.
• Had adverse side effects that over-the-counter painkillers did not have.
• Was heavily marketed to patients who did not gain to benefit from it.

Now a consumer rights group, Public Citizen, has petitioned the U.S. Food and Drug Administration (FDA) to immediately remove both Celebrex and Bextra, from the market because they increase the risk of heart attacks in patients. The group also urged the FDA to cancel plans to approve two other drugs in the same class. In 2004, more than 23.9 million prescriptions were filled in the United States for Celebrex; 12.9 million for Bextra. (Related article: Pfizer highlights the risks of recall of Celebrex and Bextra)

“If a drug offers no unique benefit compared to other drugs for treating the same problem (in this case arthritis and pain) but subjects patients to a unique risk, it must be removed from the market,” says the 12-page petition. The findings from the study by G. Caleb Alexander, M.D., M.S., instructor of medicine and a member of the MacLean Center for Clinical Medical Ethics at the University of Chicago and Randall S. Stafford, M.D., Ph.D., associate professor and Director of the Program on Prevention Outcomes and Practice at Stanford University support this argument. They found that the COX-2 inhibitors (e.g. Vioxx, Celebrex, Bextra, etc.) are no more effective in relieving pain than aspirin, ibuprofen, or any of the traditional non-steroidal anti-inflammatory drugs ( NSAIDs ), but they cause fewer of the gastrointestinal side effects that often trouble long-term high-dose NSAID users. In exchange for reduced GI risk, however, they cost 10 to 15 times as much as the drugs they replaced. The researchers also found that most people who received prescriptions were at very low or low risk for GI bleeds and thus did not really need a COX-2 inhibitor. (Related article: Vioxx approval may have been a mistake by the FDA)

Despite the guidelines, 1.7 million, or 12 percent of patients at very low risk, received COX-2 prescriptions in 1999. That number increased to 7.6 million or 40 percent of very low risk patients by 2001 before declining slightly in 2002. At the same time, 6.8 million patients, or 40 percent of those at low risk, got COX-2 drugs in 1999, which increased to 17.6 million or 66 percent of low risk patients in 2002. (Related article: Direct-to-consumer advertising for Vioxx and Celebrex)

Public Citizen’s petition on Celebrex and Bextra examines the results of 14 randomized control trials involving the five COX-2 inhibitors, as well as other published and unpublished scientific information. The other two COX-2 inhibitors are Prexige (lumiracoxib) and Arcoxia (etoricoxib), neither of which has been approved for sale by the FDA in the United States but these drugs are sold to citizens of other countries. The petition says that clinical studies suggest these drugs exhibit the same cardiovascular toxicity as Vioxx, Celebrex and Bextra, and should not be approved.

“The Food and Drug Administration should immediately ban the sale of Celebrex and Bextra, which put millions of people, many of them elderly, at risk of heart attack,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “These drugs are not only more expensive and more dangerous than older, safer pain relievers, they are no better at protecting the gastrointestinal tract,” Alexander agrees. He says, "What we saw was widespread, rapid adoption of an interesting and promising but expensive and largely untested medication by millions of people with little or nothing to gain from long-term use. The findings demonstrate the challenge of limiting innovative therapies to the settings in which they are initially targeted and maximally cost-effective."

Recommended article: FDA should have never approved Vioxx