A US judge has set the date for what could be the first trial in the USA against Pfizer’s blockbuster painkiller, the COX-2 inhibitor Celebrex (celecoxib), according to media reports.
Rosie Ware, a 53-year-old hypertension sufferer from Alabama, is taking the world’s number one drugmaker to court over claims that taking Celebrex caused her to have a stroke in February last year.
A trial date has now been set for June 6, 2006, and, if no delays occur, it could be the first of around 450 lawsuits regarding Celebrex to enter the courtroom, Jere Beasley, of law firm Beasley Allen, claims in reports.
Celebrex is a member of the multi-billion-dollar class of COX-2 inhibitors, thrown into disrepute in 2004 after the sudden withdrawal of Merck & Co’s Vioxx (refecoxib) as data surfaced showing an increased cardiovascular risk from taking the drug for more than 18 month. The product’s removal from the market sparked thousands of lawsuits against Merck; so far, the first case went against the firm but the following three were ruled in favour of the group.
Soon after, Pfizer was asked to remove its COX-2 inhibitor Bextra (valdecoxib) from the market on safety concerns, but Celebrex has been allowed to remain on the shelves. A black-box warning alerting patients to the possible risks associated with the drug’s use was added to its label in August last year, and sales have taken a substantial hit as patients are increasingly seeking alternative methods to alleviate pain. In fact, turnover of Pfizer's COX-2 franchise brought in third-quarter 2005 revenues of $734 million, a decline of more than 60% compared to the same period of 2004, when Vioxx was withdrawn.
Pfizer is gambling on a 20,000-patient study that it hopes will prove once and for all that its COX-2 inhibitor Celebrex is effective and no more likely to cause cardiovascular side effects than the older non-steroidal anti-inflammatory drugs ibuprofen and naproxen. The study is said to cost in the region of $100 million.