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Canadian Version of Chantix Gets a Warning

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A strong public warning was issued Thursday about stop-smoking pill Champix by the drug-maker and federal health officials concerned over mounting reports of mood changes, hostility, suicidal behaviour and serious, sometimes fatal, skin reactions.

Champix, the brand name of varenicline tartrate sold by Pfizer Canada Inc., must now carry a boxed warning, which is reserved for drugs that have been linked to serious safety issues or adverse events. The U.S. Food and Drug Administration has required a similar safety warning on the product since last July.

Health officials say Champix, sold in the U.S. under the name Chantix, has been linked to serious neuropsychiatric symptoms in numerous patients, including depressed mood, agitation, aggression, hostility, thoughts of self-harm or suicide. In the warning issued Thursday, Health Canada and Pfizer also highlighted reports of dizziness, loss of consciousness, seizures and other serious side effects linked to the drug.

Problems were experienced by patients with or without a history of psychiatric disorders. Alcohol intake could increase the risk to patients, Health Canada said.

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Full post as published by A Georgia Lawyer on June 08, 2010 (boomark / email).