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FDA issues further Chantix warning

The US Food and Drug Administration has issued a Public Health Advisory on new safety warnings on Pfizer's smoking Chantix (marketed as Champix in Europe and other markets).  

The US Food and Drug Administration (FDA) has issued a Public Health Advisory on new safety warnings on Pfizer's smoking Chantix (marketed as Champix in Europe and other markets). 

According to the FDA, "it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms". 

The FDA has requested that Pfizer elevates the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information, or labelling. 

In addition, FDA is working with Pfizer to finalise a Medication Guide for patients. 

The FDA first issued an Early Communication to the public and healthcare providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behaviour, agitation, depressed mood, suicidal ideation, and actual suicidal behaviour.

The FDA has advised that patients should tell their healthcare provider about any history of psychiatric illness before beginning to take Chantix, and should immediately report changes in mood and behaviour to their doctor. 

"Chantix may cause worsening of current psychiatric illness even if it is currently under control. It may also cause an old psychiatric illness to reoccur," said the FDA. 

Patients with psychiatric illness were not included in the studies carried out for Chantix's approval. 

It has also said that healthcare professionals, patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behaviour in patients treated with Chantix.

Chantix racked up sales of USD280m in Q4 2007, and it is now likely that sales will fall in 2008.

4th February 2008

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