NEW YORK, Nov. 4 /PRNewswire-FirstCall/ -- Pfizer Inc today issued the following statement in response to a report in Canada's National Post newspaper concerning the cardiovascular safety of Celebrex:
The news report, based on voluntary spontaneous event reporting to Canadian Health authorities, is misleading. 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.
Voluntary spontaneous event reporting to health authorities is not designed and cannot be used to determine cause and effect. It is essential to remember that the information provided is uncontrolled and may be second-hand or incomplete.
Health Canada has acknowledged these limitations, noting "there hasn't been a causal link established". The agency has also noted that these data contain no information about patients' underlying medical conditions.
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.
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CONTACT: Paul Fitzhenry, +1-212-733-4637, or Susan Bro, +1-212-733-5554,both of Pfizer Inc