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After Vioxx was just pulled from the market, the FDA said it was considering further studies for the other arthritis drugs in the cox-2 inhibitor class. Two reports released October 6 by the New England Journal of Medicine suggests, contrary to what federal regulators said when Vioxx was recalled, increased risk of heart attack and stroke could be a class effect, applying also to Pfizer’s drugs Celebrex and Bextra.
Dr. Garret FitzGerald, A University of Pennsylvania cardiologist leading the study, called on the FDA to change its advice to patients and doctors to reflect the new safety concerns. The medical journal also released a separate report where Dr. Eric Topol of the Cleveland Clinic criticized the FDA for not requiring Merck to do studies investigating heart problems with Vioxx when evidence first surfaced years ago.
Celebrex has been taken by 75 million Americans and is the 10th most popular drug in the U.S. With Celebrex responsible for annual sales of $2.7 billion, safety concerns for Pfizer’s Celebrex and Bextra could have significant impacts on the company’s financial and legal condition. In 2001, Public Citizen consumer group warned consumers not to use Celebrex or Vioxx, and in 2002, the group warned them not to use Bextra because of safety risks like heart attacks.