Reactions 1375 - 29 Oct 2011 Current Chantix warnings remain appropriate, says FDA Current warnings on the drug label for Chantix [varenicline], regarding the associated risks of neuropsychiatric adverse events, remain appropriate – the US FDA concludes, after a review of data from two large epidemiological trials. Neither of the two FDA-sponsored observational trials showed a significant difference in the number of neuropsychiatric hospitalisations between patients receiving Chantix and those receiving nicotine replacement therapy. However, the FDA believes that the two trials had some study design limitations, including the fact that they both only assessed the incidence of neuropsychiatric events resulting in hospitalisation, and neither had a large enough sample size to detect rare adverse events. In 2009, the FDA mandated a boxed warning for Chantix regarding the potential for serious neuropsychiatric symptoms. * While the agency continues to evaluate the associated neuropsychiatric risks, it recommends that healthcare professionals and patients continue to follow the current advice on the physician label and in the patient Medication Guide. The drug’s manufacturer, Pfizer, is conducting a large safety trial to assess the drug’s safety in terms neuropsychiatric adverse events. Results from this trial are expected in 2017. * see Reactions 1260 p2; 801075484 FDA. FDA Drug Safety Communication: Safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events. Internet Document : 24 Oct 2011. Available from: URL: http://www.fda.gov 801085507 1 Reactions 29 Oct 2011 No. 1375 0114-9954/10/1375-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved

Current Chantix warnings remain appropriate, says FDA

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Reactions 1375 - 29 Oct 2011

Current Chantix warnings remainappropriate, says FDA

Current warnings on the drug label for Chantix[varenicline], regarding the associated risks ofneuropsychiatric adverse events, remain appropriate –the US FDA concludes, after a review of data from twolarge epidemiological trials.

Neither of the two FDA-sponsored observational trialsshowed a significant difference in the number ofneuropsychiatric hospitalisations between patientsreceiving Chantix and those receiving nicotinereplacement therapy. However, the FDA believes thatthe two trials had some study design limitations,including the fact that they both only assessed theincidence of neuropsychiatric events resulting inhospitalisation, and neither had a large enough samplesize to detect rare adverse events.

In 2009, the FDA mandated a boxed warning forChantix regarding the potential for seriousneuropsychiatric symptoms.* While the agencycontinues to evaluate the associated neuropsychiatricrisks, it recommends that healthcare professionals andpatients continue to follow the current advice on thephysician label and in the patient Medication Guide.

The drug’s manufacturer, Pfizer, is conducting a largesafety trial to assess the drug’s safety in termsneuropsychiatric adverse events. Results from this trialare expected in 2017.* see Reactions 1260 p2; 801075484

FDA. FDA Drug Safety Communication: Safety review update of Chantix(varenicline) and risk of neuropsychiatric adverse events. Internet Document : 24Oct 2011. Available from: URL: http://www.fda.gov 801085507