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Scooped by Seth Bilazarian, MD
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FDA Drug Safety Communication: Safety review update of Chantix (varenicline) and risk of cardiovascular adverse events

FDA Drug Safety Communication: Safety review update of Chantix (varenicline) and risk of cardiovascular adverse events | Heart and Vascular Health | Scoop.it
FDA is informing the public about a meta-analysis of trials that compared patients who received the smoking cessation drug Chantix (varenicline). FDA first notified the public about a possible increased risk of cardiovascular adverse events with Chantix in its June 2011 Drug Safety Communication (DSC).
The meta-analysis showed higher rates of composite outcomes on Chantix. Although these findings were not statistically significant, they were consistent. It should be noted that the incidence of cardiovascular mortality (Chantix 0.05% [2/4190] vs. placebo 0.07% [2/2812]) and all-cause mortality (Chantix 0.14% [6/4190] vs. placebo 0.25% [7/2812]) was lower in the Chantix group compared to the placebo group, although this finding was also not statistically significant.
Seth Bilazarian, MD's insight:

Balancing the risk of ongoing smoking vs. these tiny differences during 6 months of treatment with Chantix will have to be made individulally by patients and their doctors.  Ideally patients quit smoking without any added drugs but for many patients addicted to smoking this is not possible.

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Chantix (varenicline) for smoking cessation does not increase risk of cardiovascular events:

Chantix (varenicline) for smoking cessation does not increase risk of cardiovascular events: | Heart and Vascular Health | Scoop.it

My comment:  There is significant concen about the safety of Chantix.  I explain to my patients that the risk of this drug has to be balanced against the risk of continued smoking (heart disease, stroke, cancer, erectile dysfunction) since this is the most effective strategy we have to help people succeed at qutitting  their addiction to niocotine.

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Danish registry of 35,000 patients comparing the safety of quitting smoking with Chantix (varenicline) comared to Wellbutrin or Zyban (bupropion) on safety of cardiovascular events.

At 6 months the rates were 0.69% vs. 7.1%.  This study found no increased risk of major cardiovascular events associated with use of varenicline compared with bupropion for smoking cessation.

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