Last week, we briefly mentioned the FDA’s new requirement of a black box warning (yes, we’re going to continue calling it a “black box warning”). This week, we had a one day trial that turned into a three day trial, so we’re just now getting to follow up on it.
The warnings will affect Pfizer’s Chantix (varenicline), GlaxoSmithKline’s Zyban and Wellbutrin (bupropion) and generic smoking cessation drugs (note—buproprion like Wellbutrin are often prescribed for depression and seasonal affective disorder). In addition to the warnings, the manufacturers will be required to create patient medication guides to fully disclose the risks of neuropsychiatric symptoms. Symptoms to be on the watch for include: hostility, agitation, depression, suicidal ideation, and behavior changes not associated with nicotine withdrawal. Those medication guides will be given to all patients who are prescribed the drugs. Finally, manufacturers are now required to conduct clinical trials to more fully explore causation.
The requirement comes on the heels of the FDA’s analysis of their MedWatch reports, which show that there may be a link between the drugs and suicidal events in patients with no history of psychiatric disease. However, the FDA first broached the topic of a possible problem back on November 20, 2007. See also the FDA’s recent newsletter on the topic here.