Champix linked to depression and suicidal thoughts

pharmafile | November 22, 2007 | News story | Sales and Marketing reg, safety 

Pfizer has alerted US regulator the FDA to cases of depression and suicidal thoughts in patients taking its smoking cessation drug Champix.

The FDA announced the news as an 'early communication' and will discuss the finding with Pfizer before deciding on what course of action to take. In the meantime the drug will remain on the market.

The concerns add another drug to the long list of products that have had their safety questioned this year, as the FDA takes a more vigilant approach to drug safety than ever before.

The US safety watchdog says a preliminary assessment shows many reported cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behaviour within a few days to weeks of patients taking Champix for the first time.

The FDA says the role of Champix (known as Chantix in the US) in these cases is not clear, because the nicotine withdrawal symptoms associated with giving up cigarettes can exacerbate underlying psychiatric illness.

But at the same time, not all patients in the reported cases had previously existing psychiatric illness and not all had quit smoking, suggesting the side effects could be directly attributed to Champix.

Champix has generated around $600 million (£290 million) in sales so far this year, with $241 million in the third quarter. This would put Champix on track to reach blockbuster status as early as next year, but new safety restrictions could seriously hamper its growth.

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