US FDA reviewing safety of varenicline

Inpharma 1616 - 1 Dec 2007

Varenicline safety under reviewThe US FDA has issued an early communication

regarding its ongoing review of safety data forvarenicline [Chantix; Pfizer], a prescription smokingcessation therapy.

The agency is evaluating postmarketing adverse eventreports submitted by Pfizer, including case reports ofsuicidal ideation among varenicline recipients.Following a case report citing erratic behaviour in apatient receiving varenicline, the regulator has alsoasked Pfizer for any information on additional casesdescribing similar behaviour among vareniclinerecipients.

Until its analysis is completed, the FDA is advisinghealthcare professionals to monitor patients receivingvarenicline for behaviour and mood changes.Consumers should contact their physician if theyexperience such changes. The agency also advises that,based on reports of associated drowsiness, patientsshould use caution when driving or operatingmachinery.FDA. FDA Issues Early Communication for Chantix. Media Release : 20 Nov2007. Available from: URL: http://www.fda.gov 809082715

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Inpharma 1 Dec 2007 No. 16161173-8324/10/1616-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved