Monday, July 06, 2009

Health Canada weighs options as U.S. FDA adds "black box" warnings

From the Ottawa Citizen:
Health Canada is still in discussions with Pfizer Inc., about whether to add safety warnings to packages containing anti-smoking drugs that may have psychiatric side effects, including suicidal thoughts.

South of the border, U.S. health officials Wednesday ordered Pfizer Inc and GlaxoSmithKline PLC to add strong "black box" warnings on their anti-smoking drugs to highlight the risk of serious mental health problems.

Philippe Laroche, spokesman for Health Canada, said the federal agency expect to reach an agreement with the pharmaceutical giant by the end of this summer, or the fall.

"In addition to updated safety information regarding the risk of psychiatric events, new labelling will also incorporate information regarding angioedema, serious skin reactions and accidental injury," said Laroche in an email to Canwest News Service.

The U.S. warnings, which must be added to Pfizer's Champix and Glaxo's Zyban, follow more than five thousand reports of depression, hostility and other behavioural changes in the U.S., the Food and Drug Administration said. ...more

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