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by Robert MacKay, Thursday, July 28, 2011 | Categories: Champix

The Food and Drug Administration in the US has added to the label of varenicline, (Champix), new safety information and the European Medicines Agency, the European drugs regulator, has said that the benefits of Champix outweigh the risks, thus quashing recent concerns regarding the safety and efficacy of this smoking cessation product.

Earlier in the year, the Food and Drug Administration published a warning about the drug after a meta-analysis was carried out by researchers at the John Hopkins School of Medicine in Baltimore and subsequently published in the Canadian Medical Association Journal.

The European Medicines Agency’s Committee for Medicinal Products for Human Use, stated that the meta-analysis carried out and the evidence gathered was not sufficient to put the safety and efficacy of the drug into question as it only reported a small number of adverse events among those who took the Champix and that among those who were taking the placebo, there were much higher dropout rates than among those on the smoking cessation product.

However, the Food and Drug Administration have also said that varenicline is successful when used by patients who suffer from cardiovascular illness who want to quit smoking but that it is also associated with a small increased risk of cardiovascular events in those patients.

The European Medicines Agency tell doctors that the risk/benefit profile of varenicline is positive still and that the meta-analysis carried out in Baltimore included too many limitations, especially the fact that there were an extremely low number of events recorded. However, the agency requested that the manufacturer submit more information on cardiovascular outcomes that might be added to the information accompanying the product.

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