November 28, 2007
Pfizer updates US label for Chantix
by Marie-Eve Laforte
Pfizer announced that the US labelling for its smoking cessation drug, Chantix, has been updated to include information about spontaneous postmarketing reports of behavioural changes, suicidal ideation and suicide in those taking the product. The revised prescribing information will also include data about postmarketing reports of depressed mood and agitation in those administered the product, the company stated.
Nonetheless, the drugmaker indicated that there is no evidence to establish a causal relationship between the adverse events and Chantix. Smoking cessation, with or without treatment, has been linked to the exacerbation of underlying psychiatric illness, Pfizer noted, and added that not all postmarketing reports involved patients with known pre-existing psychiatric illness or patients who had discontinued smoking. The news comes about a week after the FDA said that it was examining cases of suicidal ideation and behaviour in patients administered the drug.
A spokesperson for the drugmaker commented that Pfizer is in communications with European regulators regarding the labelling update in the US, and the company is "assessing the potential impact on the European product information and will continue to collaborate with the European Medicines Agency on any further developments."
Separately, the UK's Medicines and Healthcare products Regulatory Agency said it is carefully monitoring Pfizer's drug, which is sold as Champix in the country, over concerns about adverse events. The MHRA indicated that it has received 839 reports of adverse reactions related to Champix, including 46 reports of depression and 16 reports of suicidal thoughts, through the end of September. An agency spokesperson added that so far, there have been no reported suicides in patients taking the drug.
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