June 5, 2010 Health Canada and drug maker Pfizer Canada have issued stronger warnings about the smoking cessation medication Champix (sold in the U.S. under the name Chantix) 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 2009.
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.
Some patients using Champix have also experienced serious skin reactions, including angioedema, characterized by swelling under the skin that can be fatal, and other severe skin reactions, the warning said.
Champix won Health Canada approval in April 2007. In June 2008, the Health Canada issued a public advisory warning consumers about the fact a number of patients on Champix experienced behaviour changes, hostility and thoughts of self-harm. A reminder of that warning was sent to the public in January 2009 and the department also announced plans to place a stricter warning on Champix.
Champix was approved for sale in Europe in 2006. Several studies conducted in Europe on about 2,000 smokers showed that a year after initial treatment with Champix, a little more than one in five people stayed off cigarettes. Zyban's success rate is estimated at about 16 per cent. Only eight per cent of those who were given a placebo in the study had stopped smoking after a year. (Stop-smoking drug wins Health Canada approval Champix boasts 22 percent success rate, has no nicotine base)
Some Chantix (Champix) related news briefs:
Champix (Chantix) - Canada class-action lawsuit started..;
Champix (Chantix) - more serious psychiatric reactions and death..;
Smoking Cessation - Chantix (Champix) vs. Cold Turkey..;
Chantix - Pfizer faces three lawsuits surely many more to come..;
Champix (Chantix) - the risks are greater then the benefits..;
Chantix - another wrongful death lawsuit filed..;
Anti-smoking drugs (non-nicotine) - Chantix and Zyban to carry mental health warnings..;
Another Chantix Warning in Canada..;
Operators of any form of transportation warned on the use of Pfizer's smoking-cessation drug Chantix..;
Pfizer Changes Chantix Label..;
Chantix Reports of Suicidal Thoughts and Aggressive and Erratic Behavior..;