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Report: Pfizer Painkiller Celebrex Linked to Deaths

Nov 5, 2004 | AP

Canadian health officials said yesterday they have received reports linking Pfizer painkiller Celebrex to 14 deaths and numerous heart-related side effects, but that it would be premature to issue a warning or pull from the shelves.

Canada Adverse Drug Reaction Monitoring Program, part of the federal health department Health Canada, has collected 100 adverse-reaction reports on Celebrex over the past five years. Those include 19 cases of heart attack, cardiac arrest or heart failure, five strokes and included 14 deaths. Complaints are submitted to the agency directly by health professionals and consumers, and its database is meant to serve as a sort of early warning system for safety problems.

Dr. Maria Valois, director of marketed pharmaceuticals at Health Canada, told reporters on a conference call she was awaiting more information from the manufacturer on the drug's cardiac safety, clinical trials and results from other countries and agencies. She set a Nov. 18 deadline. Any further action would depend on the material submitted, she said.

"It's still premature to conclude what intervention is required in this case," Valois said.

The news conference as called after the database numbers were published yesterday in Toronto's National Post. Health Canada did not release the documents yesterday.

Canadian pharmacists filled about three million prescriptions for Celebrex last year. It is used primarily to treat arthritis.

The drug is of class called Cox-2 inhibitors, which includes Vioxx, a version manufactured by Merck that was pulled off the shelves Sept. 30 because it doubled the risk of heart attacks and strokes in patients taking it longer than 18 months.

Pfizer called reports questioning the safety of Celebrex "misleading."

"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. "It is essential to remember that the information provided is uncontrolled and may be second hand or incomplete."

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