Pfizer may re-label Champix in India after USFDA warning

P. T. Jyothi Datta Mumbai | Updated on June 24, 2011

26/02/2008 MUMBAI: Mr. Kewal Handa, Managing Director, Pfizer India launch Champix a revolutinary smoking cessation therapy drug in Mumbai on February 26, 2008. Photo: Paul Noronha   -  BL


After concern over links to suicidal thoughts, the smoke alarm has now gone off on Pfizer's tobacco-cessation product Chantix and the possibility that it may increase heart-related reactions in patients with cardiac problems.

The US Food and Drug Administration had recently asked Pfizer to continue to evaluate the product for cardiovascular risks, even as it directed the company to add the latest risk on its labelling to both doctors and patients.

“The known benefits of Chantix should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease,” the FDA said. Chantix is used as part of therapy to help smokers quit the habit, and Pfizer sells the product in India under the brandname Champix, since 2008.

On whether the enhanced labelling would be adopted on its product sold in India as well, a Pfizer spokesperson said: “We have notified the regulatory authorities about the label change and will follow their guidance accordingly. Pfizer works with regulators around the world to monitor and review data for Champix on a continual basis, update the product information as necessary and ensure that this information is made available to healthcare providers and patients.”

“Any product has side-effects and contra-indications,” points out Dr P.C. Gupta, Director of Healis Sekhsaria Institute for Public Health, adding that it comes as no surprise that tobacco-cessation products too should have side-effects.

Though the product is sold on the prescription of a doctor, the additional heart-related safety information needs to be communicated to consumers as well, he added.

Suicide alert

In September 2009, Pfizer had to update its labelling on Champix to alert health-professionals of behavioural changes including depressed moods and suicidal thoughts reportedly associated with such products.

This too followed a USFDA notification. Globally, Chantix was approved for sale in 2006 and grossed $755 million last year, media reports said.

Reports linking the product to depressed moods had dented sales, they added.

Pfizer had, in early 2009, also announced plans to collaborate with doctors working on anti-smoking programmes in India and launch about 600 clinics by 2010.

Published on June 21, 2011

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