Celebrex, Bextra recall hearings begin tomorrow

After failing to recall Adderall, a drug deemed so dangerous that Canadians are advised not to throw the unused drug in the garbage or flush it down the toilet, Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the FDA start their joint meeting to review Cox-2 inhibitor drugs (that includes drugs like Vioxx, Celebrex, Bextra, Prexige, Arcoxia, etc.) on February 16.

Adding to the controversy and lack of faith in the process is the fact that world-renowned FDA scientist Dr. David Graham is not being allowed to present his findings that are likely to embarrass the agency. With the appointment of Dr. Lester Crawford as the chairman, President Bush has simply promised more of the same at the FDA - not so admirable performance by the agency when it comes to improving the life of Americans (for example, in such matters as drug safety or being able to import prescription drugs from Canada). (Related article: FDA tries to protect Merck and Pfizer)

The review of the Cox-2 drugs will start with a couple of interesting developments during last two days as the committees try to determine if FDA should recall Celebrex and Bextra:

1. Chicago Tribune has found out that the FDA knew as early as 2002 that Vioxx was injuring Americans but did nothing. FDA's lack of action motivated Merck to keep the drug on the market resulting in 140,000 injuries by Vioxx.
2. Vioxx and Celebrex increased patients' risk of heart attack and stroke by about 20 percent while Bextra increased the risk by 50 percent, according to a study by WellPoint, the largest provider of health benefits in the United States. Pfizer pretended yesterday as if it know nothing about it. (Related article: Pfizer reaffirms Celebrex safety)
3. A research paper published in the medical journal Annals of Internal Medicine by Tai-Juan Aw, Steven Joseph Haas, Danny Liew, and Henry Krum showed higher blood pressure among patients taking Cox-2 drugs. Vioxx was the worst of all drugs and the effect was more pronounced in the elderly. The doctors are cautioning that prescription of drugs like Arcoxia, Prexige, Celebrex and Bextra be highly restricted due to potential hazards of elevated blood pressure. (Related article: Australia has already limited or banned use of Cox-2 drugs)

In the meantime, Americans are totally confused about what to do. Sales of prescription arthritis drugs continue to decline as Americans seek pain relief from drugs like Aleve and Ibuprofen. Victims of Vioxx, Celebrex, and Bextra have already filed hundreds of class action lawsuits against Merck and Pfizer as both firms refuse to take responsibility.

Recommended articles:

Celebrex attorneys seek plaintiffs

Tens of thousands of Vioxx class action lawsuit plaintiffs

Celebrex recall