Pfizer Inc has issued a statement in response to a report in Canada's National Post newspaper concerning the cardiovascular safety of Celebrex declaring the safety profile for Celebrex is well-established and is supported by extensive clinical studies in Canada and around the world.
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 statement said.
It continues, 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.
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, the statement added.
The Canadain newspaper-National Post-has reported that a class action lawsuit had been launched against the makers of Celebrex and other popular pain drugs in the same class, alleging they caused cardiovascular-related side effects ranging from high blood pressure to heart attack.