Health Canada issues stronger warnings about Chamtix,Chantix
June 9th, 2010 by Jennifer Walker-Journey
Health Canada has ordered Pfizer Canada to issue stronger warnings about its smoking cessation medication Champix, also known as Chantix in the United States, because of numerous reports of serious neuropsychiatric symptoms and some cases of the potentially fatal skin disorder, Stevens Johnson Syndrome (SJS).
Health Canada issued the warning based on adverse event reports in Canada and other countries of consumers using Champix suffering suicide-related events or the worsening of existing psychiatric disorders. The new warning says the drug should be discontinued and a doctor consulted immediately if caregivers or family members notice atypical behaviors in Champix users or if users develop a skin rash. SJS begins as a rash that blisters over causing the skin to peel off. The eyes, mouth and internal organs can also be affected, causing serious problems including dehydration and ocular problems.
In May 2008, Pfizer updated its safety information on Chantix to warn of possible serious psychiatric symptoms. In 2009, the FDA announced it was evaluating Chantix again, this time for additional side effects including serious skin reactions and accidental injury. As a result, the FDA placed a black box warning on the drug, the agency’s strongest safety warning, because of the risk of depression, suicidal thoughts and suicidal actions.