Health Canada Studying If It Will Follow U.S. FDA In Placing Black Box Warnings On Anti-Smoking Drugs

July 3, 2009 2:54 p.m. EST

Ottawa, Ontario (AHN) - The results of talks between Health Canada and Pfizer Inc. will determine the course of action Ottawa will make if it will place safety warnings on packaging of anti-smoking drugs known to have psychiatric side effects such as suicidal thoughts.

Health Canada spokesperson Philippe Laroche said the agency expects an agreement with Pfizer may be signed by end of summer or fall.

Laroche, in an email to CanWest News Service, said, "In addition to updated safety information regarding the risks of psychiatric event, new labeling will also incorporate information regarding angiodema, serious skin reaction and accidental injury."

On Wednesday the U.S. Food and Drug Administration mandated Pfizer and GlaxoSmithKline to include strong black box warnings on their anti-smoking medication to emphasize the risk drinkers may face, particularly of serious mental health problems.

Earlier this year Health Canada issued a health warning against varenicline tartarate, a medication for quitting the nicotine habit. The drug is marketed by Pfizer. In Europe it is known under the brand Champix, while in the U.S. it is sold as Chantix.