The European Medicines Agency (EMEA), the European equivalent to the FDA, has decided that new advice is needed to warn both doctors and patients a possible link between Pfizer’s stop smoking drug Champix, marketed as Chantix in the U.S., and suicide. The decision has been made to include a warning for depression, suicidal ideation or thoughts, and the possibility of suicide. Australian authorities announced last week that the drug will be sold with a similar warning when it hits the Australian market in January of 2008.
The Committee for Medicinal Products for Human Use (CHMP) has been closely monitoring the safety of Champix since it was first authorized in the European Union (EU) in September 2006. As part of the routine pharmacovigilance activities, all adverse reactions for Champix are analyzed on a regular basis. Cases of suicidal ideation and suicide were reviewed in July, October and November 2007.
The FDA has also launched an investigation of the drug. Numerous reports of suicide and suicidal ideation have been reported to the FDA’s adverse event reporting system. Pfizer claims that Chantix is safe and backs this up by stating that clinical trials did not demonstrate an elevated risk in these areas.
The future of Chantix in the U.S. is still up in the air, but it is clear that concerns about possible side effects have made a large enough impression to persuade foreign agencies to add additional warnings to the drug.
For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.