Chantix Manufacturer Slapped With Lawsuit
Thursday, July 10, 2008
The spouse of a man who apparently committed suicide after using Pfizer Inc.'s smoking-cessation drug Chantix has sued the drug manufacturer, claiming Pfizer failed to properly warn of the pill's psychiatric side effects.The Chantix lawsuit, filed in federal court in Indianapolis, Indiana, on July 8, 2008, is one of the first brought against New York-based Pfizer since safety concerns about the drug began to surface last year.
In a written statement, Pfizer said it was aware of the suit but hadn't yet been served with a copy. The company plans to file a formal response. Pfizer said it believes it has acted "responsibly, appropriately and in the best interests of patient safety" in connection with Chantix.
The lawyer, who filed the suit, believes it will kick off a wave of Chantix product-liability litigation for Pfizer.
The lawsuit claims that the widow’s husband shot himself to death in January. He had begun using Chantix in late October 2007, according to the lawsuit. Additionally, the lawsuit argues that Pfizer should have known that Chantix was associated with psychiatric side effects and should have warned about them sooner than it did.
In February, the FDA issued a safety warning for Chantix, saying it appeared increasingly likely that there may be an association between the drug and serious mood and behavior symptoms. At that time, the FDA said it had received about 39 reports of suicides globally and 491 reports of suicidal thoughts or behaviors possibly linked to Chantix. The FDA had announced in November it was looking into Chantix's safety.
In January, Pfizer revised the drug's prescribing label to warn about the post-marketing reports of suicidal behavior and mood problems. Pfizer said Chantix users should be observed for serious neuropsychiatric symptoms. Pfizer has defended Chantix, saying it is effective in helping people stop smoking, which is a major public-health problem.
Chantix went on sale in 2006 and sales rose briskly, totaling $883 million for 2007. But prescription volume has been hurt by the safety concerns. An estimated 7.5 million people worldwide have taken Chantix since its approval in 2006, Pfizer said.
Posted in Dangerous Drugs • Chantix