Saturday, February 02, 2008

Quit-smoking drug linked to serious psychiatric side-effects: FDA

From the Canadian Press:
The U.S. Food and Drug Administration issued a public health warning Friday about a highly touted smoking cessation drug after it was linked to potentially serious neuropsychiatric symptoms.

Adverse effects have been reported in relation to the prescription medication Chantrix (varenicline), which is sold in Canada under the brand name Champix, including changes in behaviour, agitation, depressed mood, and suicidal thoughts and behaviour.

The FDA has requested that Pfizer, the drug's manufacturer, add the new safety information to the warnings and precautions section of the medication's prescribing information or labelling. The agency also is working with Pfizer to finalize a medication guide for patients.

"Chantix has proven to be effective in smokers motivated to quit, but patients and health-care professionals need the latest safety information to make an informed decision regarding whether or not to use this product," Dr. Bob Rappaport, director of the FDA's division of anesthesia, analgesia and rheumatology products, said in an advisory. ...more

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