Arthritis drug Celebrex safe: Pfizer

NEW YORK – Pharmaceutical giant Pfizer has reaffirmed its view that its arthritis drug Celebrex is safe, while a Canadian health official said the risk of cardiovascular problems cannot be ruled out.

The company responded with a statement after the National Post, citing documents from Health Canada, reported that Celebrex had been suspected of causing 14 deaths and other serious side effects. Pfizer said the report was “misleading” and based on non-scientific evidence.But in Canada, health ministry official Maria Valois said the risk cannot be ruled out.”There is a possible risk” Valois said.”We are now evaluating whether this is a serious risk.”Celebrex has been in focus since last month’s withdrawal by Merck of its Vioxx, a similar product, due to concerns Vioxx could cause heart attack or stroke.Pfizer has insisted that Celebrex has not had similar problems, and that the Canadian report provided nothing to prove otherwise.”The news report, based on voluntary spontaneous event reporting to Canadian health authorities, is misleading,” Pfizer said in a statement.”The story is not supported by any clinical or epidemiological studies and has the potential to cause undue confusion among patients and physicians.The safety profile for Celebrex is well established and is supported by extensive clinical studies in Canada and around the world.”Pfizer said Health Canada had acknowledged the limitations of the anecdotal reports and had noted, “There hasn’t been a causal link established.”Valois said Canadian officials were studying the circumstances of the deaths.”There are some cases that cannot be evaluated, others where there is little likelihood (of a link to Celebrex) and others where it is possible but cannot be confirmed,” she said.”There is no case among the 14 where there causality linked to Celebrex has been absolutely confirmed.”Celebrex represents some US$2,29 billion (N$14 billion) in annual sales for Pfizer, one of the company’s leading products.-Nampa-AFPPfizer said the report was “misleading” and based on non-scientific evidence.But in Canada, health ministry official Maria Valois said the risk cannot be ruled out.”There is a possible risk” Valois said.”We are now evaluating whether this is a serious risk.”Celebrex has been in focus since last month’s withdrawal by Merck of its Vioxx, a similar product, due to concerns Vioxx could cause heart attack or stroke.Pfizer has insisted that Celebrex has not had similar problems, and that the Canadian report provided nothing to prove otherwise.”The news report, based on voluntary spontaneous event reporting to Canadian health authorities, is misleading,” Pfizer said in a statement.”The story is not supported by any clinical or epidemiological studies and has the potential to cause undue confusion among patients and physicians.The safety profile for Celebrex is well established and is supported by extensive clinical studies in Canada and around the world.”Pfizer said Health Canada had acknowledged the limitations of the anecdotal reports and had noted, “There hasn’t been a causal link established.”Valois said Canadian officials were studying the circumstances of the deaths.”There are some cases that cannot be evaluated, others where there is little likelihood (of a link to Celebrex) and others where it is possible but cannot be confirmed,” she said.”There is no case among the 14 where there causality linked to Celebrex has been absolutely confirmed.”Celebrex represents some US$2,29 billion (N$14 billion) in annual sales for Pfizer, one of the company’s leading products.-Nampa-AFP