Other safety alerts
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| The United States: Chantix (varenicline) and Zyban (bupropion): Drug Safety Communication - Mental Health Side Effects Revised |
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The U.S. Food and Drug Administration (FDA) review of a large clinical trial that FDA required the drug companies to conduct, FDA determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) is lower than previously suspected.
As a result of the large clinical trial review, FDA is removing the Boxed Warning, FDA’s most prominent warning, for serious mental health side effects from the Chantix drug label. The language describing the serious mental health side effects seen in patients quitting smoking will also be removed from the Boxed Warning in the Zyban label. FDA is also updating the existing warning section in both labels that describes the side effects on mood, behavior, or thinking to include the results from the clinical trial. The patient Medication Guide that explains the risks associated with the use of the medicines will continue to be provided with every patient prescription; however, the risk evaluation and mitigation strategy (REMS) that formally required the Medication Guide will be removed.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm533517.htm
In Hong Kong, there are three registered pharmaceutical products containing varenicline namely Champix Tab 0.5mg (HK-55479), Champix Tab 0.5mg & 1mg (HK-55462) and Champix Tab 1mg (HK-55437), while there are five registered products containing bupropion, namely Zyban Sustained-Release Tab 150mg (HK-46946), Wellbutrin SR Sustained-Release Tab 150mg (HK-52125), Wellbutrin XL Extended Release Tab 300mg (HK-58253), Wellbutrin XL Extened Release Tab 150mg (HK-58371) and PMS-Bupropion SR Tab 150mg (HK-58534). All these products are prescription only medicines. News about the risk of psychiatric symptoms on varenicline issued by the TGA and FDA were posted on the Drug Office website on 2 December 2015 and 10 March 2015 respectively. Letters to inform local healthcare professionals were issued on 10 March 2015. The Department of Health remains vigilant on the safety update of products containing varenicline and bupropion.
Ends/ Saturday, December 17, 2016
Issued at HKT 12:30
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