Will Warn About Risk Of Serious Neuropsychiatric Symptoms Including Agitation, Depression, Suicidal Thoughts, And Attempted Suicide

(Posted by Tom Lamb at DrugInjuryWatch.com)

On July 1, 2009 the FDA issued a Public Health Advisory about Chantix (varenicline) as well as Wellbutrin (bupropion) and Zyban (bupropion) which announced that these smoking cessation drugs will be getting a so-called "black-box" warning:

…highlighting the risk of serious neuropsychiatric symptoms in patients using these products. These symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide. The added warnings are based on the continued review of postmarketing adverse event reports for varenicline and bupropion received by the FDA. These reports included those with a temporal relationship between the use of varenicline or bupropion and suicidal events and the occurrence of suicidal ideation and suicidal behavior in patients with no history of psychiatric disease.

Contemporaneous with this July 1 FDA Public Health Advisory the FDA issued a news release — "FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban" — and a document intended primarily for relevant medical professionals — "Information for Healthcare Professionals: Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)".

This second item had some concise and helpful background information about the history of safety issues concerning Chantix, Wellbutrin, and Zyban:

FDA first informed the public about the possibility of serious neuropsychiatric symptoms with [Chantix] in the November 20, 2007 FDA Early Communication About an Ongoing Safety Review.  A complete history of related communications on [Chantix] and [Wellbutrin / Zyban] can be found at: Varenicline (marketed as Chantix) Information.  Since that time, information about serious neuropsychiatric symptoms in patients taking varenicline has been added to the POST-MARKETING EXPERIENCE section of the prescribing information.

As FDA received additional information the suggestion of a possible association between both varenicline and bupropion (which was evaluated as a comparator to varenicline) and serious neuropsychiatric symptoms, in both patients with and those without previous history of psychiatric illness, became more evident as its review progressed….

We will watch for corporate press releases from Pfizer (which sells Chantix) as well as GlaxoSmithKline (which sells Wellbutrin and Zyban) which might be issued to present the drug company's reaction to this FDA announcement about adding a black-box warning for neuropsychiatric side effects being added to their respective product's Package Insert, or label.