The European Medicines Agency has decided that Pfizer’s smoking cessation drug Champix, marketed as Chantix in the States, needs to include a an updated warning to inform physicians and consumers of the possibility of depression, suicidal thought and even suicide attempts associated with the drug. There have been reports of several suicides and numerous claims of suicidal ideation attributed to the Champix. Pfizer maintains that there is no clinical evidence to suggest a causal relationship.
The FDA has also launched an investigation to examine similar reports from patients taking Chantix in the United States. Last week Australian authorities announced that Champix will carry a depression and suicide warning when it is introduced to the Australian market in January of 2008. The Committee for Medical Products for Human Use (CHMP) has requested that Pfizer submit a new variation of the label by the December 19 in order to implement the changes to the product information.
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