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by Robert MacKay, Tuesday, June 21, 2011 | Categories: Champix

Pfizer’s smoking cessation product, Chantix (Champix) will be relabelled after the FDA’s (Food and Drug Administration) latest recommendation. The drug has been associated with heart problems in those who suffer from cardiovascular disease.

The FDA is changing the label in order to highlight the danger of the drugs active ingredient, Varenicline Tartrate, and its association with increased risk of heart problems after results of a new clinical trial were announced. It is important to stress however that the drug was found to increase risk only in those who had a pre-existing cardiovascular condition.

The FDA make sure that Chantix carries a black box warning which is the most serious label used by the regulators. After the news regarding such side effects and also an association with depression and suicidal ideation and erratic behaviour, the FDA decided that all of these side effects needed to be included on the warning label. Side effects relating to depression, reports of feelings of aggression and suicidal behaviour have not been found in clinical trials to be of a significant enough number to suggest the drug is dangerous but nevertheless, they must be listed as possible side effects.

An independent trial took place where 700 smokers, who already had cardiovascular disease, were observed. They were treated with either the drug in question or a placebo. The results show that the drug was successful in helping patients to stop smoking. Those who took the drug were also more inclined to suffer a cardiovascular problem than those who were taking the placebo.

The FDA will require Pfizer to carry out a large-scale trial in order to assess the risk associated and would later discuss the outcomes with the manufacturer. The risk-benefit profile of this drug is under scrutiny now but perhaps this will mean that it is merely contraindicated for those who suffer from cardiovascular illness.

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