The FDA has ordered Pfizer Inc., maker of Chantix, to add the strong “black box” warnings – the agency’s most urgent – to this anti-smoking drug reports Forbes.com. The FDA says patients taking Chantix should be watched for serious mental health problems including suicide.
The FDA will require the same warning on GlaxoSmithKline’s Zyban. The warning must also be included in all advertisements for these drugs. Nicotine-releasing patches and gums will not carry the warning.
The FDA stated the warning will highlight the risk changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.
Although GlaxoSmithKline wasn’t available for comment, Pfizer said it added the warning to the prescribing instructions, but added “the benefits of Chantix outweigh the risks for many patients when used as directed..