Other safety alerts
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| The United States: Chantix (varenicline) - updated study data |
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FDA has reviewed the results from two FDA-sponsored epidemiological studies that evaluated the risk of neuropsychiatric adverse events associated with the smoking cessation drug Chantix (varenicline). Neither study found a difference in risk of neuropsychiatric hospitalizations between Chantix and nicotine replacement therapy. However, both studies had a number of study design limitations, including only assessing neuropsychiatric events that resulted in hospitalization, and not having a large enough sample size to detect rare adverse events. Healthcare professionals and patients should continue to follow the recommendations in the physician label and the patient Medication Guide, and to monitor for neuropsychiatric symptoms when prescribing or using Chantix. The drug manufacturer is conducting a large safety clinical trial of Chantix to assess neuropsychiatric adverse events, and results from this study are expected in 2017.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm079818.htm
In Hong Kong, varenicline is registered as Champix Tab 0.5mg and 1mg by Pfizer Corporation HK Ltd. and are prescription medicines. The news has been released by the US FDA and other regulatory authorities previously and was posted on the website of Drug Office in Jun and July 2011. A letter to inform healthcare professionals was issued on 17 June 2011. Department of Health will keep vigilance against any new safety information related to the drug.
Ends/ Tuesday, October 25, 2011
Issued at HKT 12:30
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