Is Celebrex safe?
Pfizer Inc. defended the safety of its painkiller Celebrex on Thursday after a newspaper reported that documents from Canadian health authorities linked the drug to the deaths of 14 people who were taking it over the past five years.
The documents include more than 100 adverse-reaction reports on Celebrex over the past five years, including 19 cases of heart attack, cardiac arrest or heart failure and five strokes, the Canadian newspaper National Post reported.
The company said that millions of patients have been prescribed Celebrex since it was first approved in 1998 and large-scale clinical studies of up to four years showed no increased cardiovascular safety risk.
Pfizer said the Canadian agency, Health Canada, has noted that “there hasn’t been a causal link established” between the events and Celebrex. The agency has also noted that incidence reports didn’t contain information about other underlying medical conditions that the patients might have had, Pfizer said.
Celebrex has been touted as a safer alternative to Vioxx, the painkiller Merck & Co. pulled from the market in September after it led to higher rates of heart attacks and strokes. Pfizer, which is based in New York, actually plans to conduct a long-term study of Celebrex to see if it helps the heart.
However, questions remain over the safety of the whole class of drugs, called Cox-2 inhibitors, which also includes Pfizer’s drug Bextra.
“Given the absolute numbers described here, and the fact that hundreds of thousands of Canadian patients have been exposed to this drug, we believe that the reported incidence of events is not in any way alarming,” Deutsche Bank Securities analyst Barbara Ryan wrote in a Thursday research note. “In fact, the absolute number of events would be expected to be higher in a population of this size — with no causal effect — in our opinion.”
Dr. Patrice Roy, Pfizer Canada’s director of scientific affairs, told the National Post that the Health Canada adverse reaction information is important but far from conclusive. Celebrex hasn’t posed a threat to cardiovascular safety in clinical studies, he said.
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