FDA gets 5,000 Chantix complaints

Chantix

Talk about an outpouring of adverse-event reports. After WFAA-TV in Dallas reported musician Carter Albrecht's violent death--perhaps under the influence of Pfizer's smoking-cessation drug Chantix--more than 5,000 complaints about the med's side effects poured into the FDA. And the complaints were serious: 55 reported suicide, 199 reported suicidal thoughts, and 417 complained of depression, according to the TV station, which obtained the reports. Hundreds of others mentioned anger, aggression, amnesia, hallucinations, and homicidal thoughts.

You'll recall that the FDA announced last week that it would investigate Chantix's safety after reports of psychiatric side effects, including one instance of "erratic" behavior. That apparently was Albrecht, who ranted and raved at a neighbor's door until the neighbor shot him. An FDA spokesperson told WFAA that it is looking into 100 "specific psychotic incidents" in the U.S. The agency also said it had already intended to investigate the drug because of complaints in Europe when news of Albrecht's death broke.
 

Related Articles:
'Erratic' behavior triggers Chantix probe. Report
Chantix outperforms Zyban in major study. Report
Addex smoking cessation drug misses endpoint. Report

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.