As a follow up to the last post, Pfizer announced last Friday that they have agreed to pay $894 million to settle 3 lawsuits that alleged Celebrex and Bextra harmed patients in the U.S. and defrauded consumers. The suits claimed that Bextra and Celebrex resulted in increased risks of heart attacks and strokes.
There were rumors as early and May 2008 of a settlement. At that time the Wall Street Journal reported that attorneys for Pfizer were in negotiations with representatives of the plaintiffs. Pfizer did not confirm the settlements until the press release issued last week.
Of the $894 settlement, $745 million will go toward settling injury claims, $89 million for Bextra and Celebrex class action consumer fraud suits, and $60 million for state attorney general settlements over marketing practices related to Bextra.
The U.S Food and Drug Administration (FDA) asked Pfizer to withdraw Bextra in 2005, less than 4 years after its approval by the FDA. This was due to mounting evidence of increased cardiovascular risks and reports of a potentially fatal skin reaction called Stevens-Johnson syndrome.
Bextra and Celebrex are in the same class of drugs as Vioxx, which was previously withdrawn from the market in September 2004. Merck, the maker of Vioxx, has resolved most of the thousands of claims of injury by U.S. patients in a $4.85 billion settlement.
Celebrex remains as the only cox-2 inhibitor still available on the market today. According to Pfizer, state and federal courts have ruled that there is no reliable scientific evidence that Celebrex increases the risk of stroke and heart attacks. However, the FDA required all prescription non-steroidal anti-inflammatory drugs (NSAIDs), including Celebrex, to carry a “black box” warning about potential increased risk of heart attacks, stroke and gastrointestinal problems.