Times of India
27June 2011
By Rupali Mukherjee
Mumbai,India

Smokers popping the pill to kick the butt need to be cautious. The US Food and Drug Administration has said anti-smoking pill varenicline (marketed as Chantix or Champix by Pfizer) may be associated with a marginally increased risk of cardiovascular problems in people who already have heart problems.

Doctors say the pills should be monitored if prescribed and not given to those suffering from heart diseases. Dr Ashok Mahashur, consultant chest physician at Hinduja Hospital, said: “The drug should be prescribed under strict supervision and closely monitored. Though strong data is awaited to establish the risk, it should not be advised to patients who are suffering from a heart problem.”

Dr Ashok Seth, chairman of Fortis-Escorts Heart Institute, further said the risk-benefit ratio in every individual needs to be assessed before prescribing the pill and its indiscriminate use should be avoided. “This is an important drug for smokers who are quitting the habit, but we need to be cautious (after this),” he said.

In the US, health regulators have already asked for a change in the label of Chantix. A Pfizer official said about their label change: “We have notified the Indian regulatory authorities about the label change and will follow their guidance accordingly.”

In an independent randomized clinical trial, 700 smokers, who had cardiovascular disease, were treated with Chantix or a placebo showed that the Pfizer drug was effective in helping patients quit smoking for a year.