FDA Orders Black Box Warning for Pfizer drug Chantix® - Suicide Links Investigated

July 2, 2009 - Birmingham, AL

With suicide reports on the increase, The U.S. Food and Drug Administration (FDA) has ordered Pfizer, Inc. to place a “Boxed Warning” on its smoking cessation drug, Chantix. The July 1, 2009 order for a so-called Black Box Warning comes on the heels of Adverse Events Reports and lawsuits linking Chantix® to serious injuries and death. The FDA Advisory noted “These reports included those with a temporal relationship between the use of [Chantix] and suicidal events and the occurrence of suicidal ideation and suicidal behavior in patients with no history of psychiatric disease.”  In addition to requiring a stronger Boxed Warning, the FDA is requiring Pfizer to “develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms.”  The FDA Advisory also requires new “Black Box” warnings to be included on packages of smoking cessation drug Zyban® (buproprion).   

Attorney Kristian Rasmussen of Cory Watson Crowder and DeGaris in Birmingham, Alabama, filed the first lawsuits in the country on behalf of Chantix® victims. Rasmussen charges there is  “alarming evidence linking Chantix® to many severe injuries and deaths. Pfizer rushed this dangerous drug onto the market.” 

Rasmussen says Cory Watson Crowder and DeGaris has received more than 2,900 inquiries from consumers from across the country.  Rasmussen said his firm currently represents more than 350 Chantix victims. Cory Watson Crowder & DeGaris is recognized nationally for its practice in mass torts litigation of defective medical devices and pharmaceuticals, class actions, multidistrict litigation and complex litigation including business and securities litigation and environmental litigation. www.cwcd.com

Media contact Melanie McCraney   mmccraney@cwcd.com    (205)910-1323