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Pfizer set for Celebrex trial in June

Plaintiff attorneys will argue that COX-2 caused their client to suffer a stroke

Pfizer is soon to face the first product-liability trial over its COX-2 painkiller Celebrex, after an Alabama judge set a June 6 date for the lawsuit to commence.

Plaintiffs for Rosie Ware, 54, will contend that Celebrex, the only COX-2 still available on the US market, was responsible for a stroke she suffered a year ago and that Pfizer and companies it has since acquired understated the risks of the drug and failed to warn consumers of possible side effects.

Two other COX-2s, Merck's Vioxx and Pfizer's Bextra have both been withdrawn from the market amid safety concerns. Vioxx was pulled in September 2004 after a Merck study showed it doubled the risk of heart attacks and strokes in patients after 18 months of use. Bextra was taken off the market last April after the US Food and Drug Administration voiced its concerns over heart risks.

In August, Pfizer stuck a `black box' warning on Celebrex, recommending to doctors that it only be prescribed at the lowest dose and the shortest time possible. The label also warns that the drug may increase the risk of cardiovascular events, including heart attack and stroke.

Ware is to be represented by Beasley, Allen, Crow, Methvin, Portis & Miles PC, the law firm that was recently defeated in the first federal Vioxx trial.

Ware's attorney Jere Beasley said his client was a non-smoker who had been in very good health before her stroke and had taken Celebrex for back pain. He alleges that taking the drug left her disabled and unable to work.

Beasley told the Wall Street Journal he was undeterred by the fact that Celebrex has been deemed safe by regulatory agencies. ìI don't think that makes much difference,î he said. ìThe FDA is just an extension of the drug industry.î

ìThe FDA, [the European Medicines Agency] and other health authorities around the world have concluded that the benefits of Celebrex continue to outweigh its risks, and, as a result, Celebrex is the only COX-2 inhibitor remaining on the market today,î said a Pfizer spokesman.

Sales of Celebrex have suffered as a result of the safety concerns. Annual sales for 2005 fell 48 per cent to $1.73bn although the market share of new prescriptions for Celebrex rose by 10 per cent partly due to patients switching from Bextra after it was withdrawn.

About 450 lawsuits have been filed over Celebrex, according to Beasley.

30th September 2008

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