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Arrhythmia Watch team

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VARENICLINE – BENEFIT VS. RISK IN FDA LABEL UPDATE

New safety information for smoking cessation aid varenicline will be included on the updated label approved recently by the US Food and Drug Administration (FDA).1

The updated label includes the FDA’s recommendation that the proven benefits of varenicline for smoking cessation be weighed against its association with “a small, increased risk of certain cardiovascular adverse events” in patients with cardiovascular disease.  The FDA communicated this risk in its June 16th Drug Safety Communication.

The FDA reviewed of a clinical trial of 700 smokers with cardiovascular disease, randomised to either varenicline or placebo for 12 weeks and followed up for an additional 40.  The trial demonstrated both the drug’s efficacy in aiding both smoking cessation and abstinence, as well as its association with the risk of cardiovascular events.

The updated label also states that as well as starting to take varenicline seven days before their quit date, as previous labelling has recommended, patients may alternatively start treatment and then quit smoking between days eight and 35 of treatment.

The benefit vs. risk balance of varenicline remains positive, according to the European Medicines Agency (EMA),2 although their Committee for Medicinal Products for Human Use (CHMP) has requested that its product information include further data on cardiovascular events.

References

1 Food and Drug Administration. FDA drug safety communication: Chantix (varenicline) drug label now contains updated efficacy and safety information. 2011.  (Available from: http://www.fda.gov/Drugs/DrugSafety/ucm264436.htm)

2 European Medicines Agency. European Medicines Agency confirms positive benefit-risk balance for Champix [press release]. July 21, 2011. (Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/07/WC500109177.pdf)

Published on: September 7, 2011

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