FDA orders Black Box Warning for Pfizer Smoking Cessation Drug Chantix®
Kristian Rasmussen July 1st, 2009
The FDA today mandated a “Black Box” Warning” requiring Pfizer Inc., manufacturer of Chantix®, to strengthen warnings about the health risks and dangers associated with using the drug. Chantix® is advertised as an aid to help people quit smoking. The order for a Boxed Warning comes on the heels of thousands of reports linking Chantix® to serious injuries and death. FDA officials 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.”
WhenI filed the first lawsuits in the country on behalf of Chantix victims in 2007, Pfizer knew how dangerous Chantix is, yet they failed to properly warn consumers or physicians. Alarming evidence linking Chantix to many severe injuries and death has continued to mount since Pfizer rushed the dangerous drug onto the market. Our firm has received more than 2,900 inquiries from consumers from across the country and we currently represents more than 350 Chantix victims. If you would like to discuss Chantix litigation or refer a case, please contact me krasmussen@cwcd.com or Elizabeth Ellis Chambers, bchambers@cwcd.com or phone toll free (800) 852-6299.