NEW YORK, NY (November 8, 2004) – Pfizer Inc. last week labeled “misleading” a report in Canada’s National Post newspaper concerning the cardiovascular safety of Celebrex.
Pfizer said the news report was based on voluntary spontaneous event reporting to Canadian Health authorities and was “not supported by any clinical or epidemiological studies.” The company said the report “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 in a statement issued Thursday.
Voluntary spontaneous event reporting to health authorities is not designed and cannot be used to determine cause and effect, the company said. “It is essential to remember that the information provided is uncontrolled and may be second-hand or incomplete,” the Pfizer statement continued.
According to Pfizer, Health Canada has acknowledged these limitations, noting “there hasn’t been a causal link established,” and that “these datacontain no information about patients’ underlying medical conditions.”
Pfizer said that millions of patients have been prescribed Celebrex since its first approval in 1998 and large-scale clinical studies of up to four years showed no increased cardiovascular safety risk.
