FDA Review Panel Recommends Leaving Black Box Warnings on Chantix
Although the FDA does not legally have to follow recommendations or guidelines from review panels, the federal regulatory agency often does follow panels’ advice.
Federal regulators also say that Pfizer, the pharmaceutical giant behind Chantix, has provided “low quality evidence” supporting a change in Chantix’s label. The anti-smoking drug has carried a black box warning – the FDA’s strongest possible warning for drug side effects – since 2009.
Staff scientists noted that they were “concerned about the validity” of data that Pfizer submitted, which, unlike other studies, shows that Chantix does not lead to suicidal thoughts or depression. Pfizer had previously been required to conduct a comprehensive study of the psychological effects of Chantix, so the pharmaceutical company submitted five company-sponsored studies to the FDA, which measured suicidal tendencies through a questionnaire. FDA scientists said that these studies provided “evidence of insufficient quality to either rule in or rule out increased risk of suicide.”
Last year, Pfizer settled 2,900 personal injury lawsuits involving claims of psychological disorders and terrible side-effects from taking Chantix. The company offered $300 million to the Alabama-based multidistrict litigation (MDL). Now, the company seeks to completely rid itself of controversy around Chantix by having the label removed from their drug. On Monday, October 6th, US District Court Judge Inge Johnson, who oversaw the Chantix MDL in Alabama, entertained a motion to dismiss the remaining personal injury lawsuits.
Despite dismissal of the remaining Chantix injury lawsuits, the FDA still receives adverse event reports involving the anti-smoking drug. Between January 2013 and June 2014, the regulatory agency received 105 reports of psychological changes related to Chantix prescriptions.
The drug works by blocking “feel-good” chemicals released by the brain which make smoking a rewarding experience for addicts. However, this same blocking mechanism can prevent those good chemicals from releasing at other times, which can trigger depression or suicidal thoughts.
Last week, five consumer groups banded together to petition the FDA not to remove the warning label, and in fact, make it stronger based on newer studies than those cited by Pfizer. The groups say that Chantix causes distinct and distressing psychological side-effects like suicidal ideation and behavior, aggression and violence, psychosis, and depression.
“It is important for the FDA to revisit the warnings because its 2008 assessments, through no fault of the agency, substantially underestimated the psychiatric adverse effects and accident risks,” according to the petition, which was filed by the Institute for Safe Medication Practices; Consumer Reports; the National Center for Health Research; the National Physicians Alliance and Public Citizen.
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