Pfizer finds heart attack risk with Celebrex
Pfizer recently announced that it suspended use of its popular painkiller Celebrex in a cancer-prevention study after the medicine showed an increased risk of heart attacks.
According to Pfizer, the cardiovascular findings in one of the studies is unexpected and not consistent with the reported findings in a second study.
"Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world,” said Hank McKinnell, Pfizer chairman and chief executive officer.
Pfizer said it has no plans to pull Celebrex from the market.
Five days after Merck & Co. announced the voluntary withdrawal of Vioxx because a study indicated the drug could have potential cardiovascular risks, Edwardsville plaintiff's attorney Mike Bilbrey filed a consumer fraud class action complaint against Merck, with his mother, Patricia, as the named plaintiff.
Approved by the Food and Drug Administration in 1998, Celebrex is a COX-2–specific inhibitor used for treating osteoarthritis and rheumatoid arthritis.
Celebrex is in the same category as Vioxx, which was recalled Sept. 30.
Pfizer said the increased risk was found in one of two long-term cancer prevention trials, while the other trial showed no increased risk.
The National Cancer Institute, which was conducting the study for Pfizer, suspended the use of Celebrex after discovering that patients taking 400 to 800 miligrams of the drug daily had a two-and-a-half times greater risk of experiencing major heart problems than those who were taking a placebo.
Pfizer was conducting the trials as part of an effort to find a new application for the drug.
“Celebrex is an important medicine that provides necessary pain relief to many patients," according to McKinnell.
"Patients being treated with Celebrex should discuss appropriate treatment options with their healthcare professionals. Physicians should factor this new information, as well as ulcer risks and gastrointestinal bleeding seen with traditional NSAIDs, into their prescribing decision."
Pfizer has been named in 4 class action lawsuits in Madison County.