BETHESDA, MD 01 July 2009—FDA announced today that the makers of bupropion and varenicline products must more prominently display warnings about the risk of serious mental health events occurring during therapy.
The more prominent display, a boxed warning, will highlight the risk of patients exhibiting changes in behavior, a depressed mood, and hostility and having suicidal thoughts while using the product, the agency said.
FDA-approved labeling for Chantix, Pfizer Inc.`s varenicline product, already mentioned the risk of these serious mental health events, also known as serious neuropsychiatric symptoms.
But the labeling for Zyban, GlaxoSmithKline`s sustained-release bupropion product, emphasized the risk of suicidal thinking and behavior, as does the labeling for other products containing an antidepressant. Since 2005, this risk of "suicidality" has been highlighted in a boxed warning in the labeling for bupropion products.
Both Chantix and Zyban are intended to help patients stop smoking. Bupropion has been marketed as an antidepressant since 1985.
FDA said the boxed warning highlighting the risk of serious mental health events during the use of either smoking-cessation product is based on a review of adverse-event reports received by the agency and analysis of information from clinical studies and the scientific literature.
Curtis Rosebraugh, director of the FDA office that evaluates smoking-cessation products, said during a media briefing that the agency reviewed 98 reports of completed suicides among varenicline users and 14 such reports among bupropion users. It also reviewed 188 reports of attempted suicides among varenicline users and 17 such reports among bupropion users. Some of those reports might have been duplicates, he cautioned.
FDA decided, he said, that the products` existing warnings are "especially important to prescribers" and warrant being highlighted in a box.
"There is a serious adverse reaction that can be prevented or perhaps reduced in frequency or severity by appropriate use of the drug, which would include careful monitoring," Rosebraugh said.
Addition of the boxed warning to varenicline`s labeling and expansion of the boxed warning in bupropion products, he said, does not mean that FDA is creating new contraindications for those products.
The term "black-box warning"—widely used by the public when referring to a boxed warning—is a misnomer, said Robert J. Temple, director of FDA`s office of medical policy.
"We`ve been trying to get the entire world to stop calling these things black boxes and call them what they`re supposed to be called—boxed warnings," Temple said.
"Black box," he continued, "carries the implication `don`t you dare use this,` and that is absolutely not [being said] in this boxed warning. We don`t think people shouldn`t use smoking-cessation" products."