FDA Review Panel Recommends Leaving Black Box Warnings on Chantix
The FDA is set to review evidence submitted by Pfizer in their request to remove serious warnings from their anti-smoking drug, Chantix, which suggest that the drug can trigger depression and suicidal thoughts, among other side effects. However, an FDA review panel has looked at the evidence Pfizer presented, as well as evidence submitted from consumer advocacy groups, and the panel suggests that the warning labels on Chantix should not be removed.
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.
The Strom Law Firm Can Help with Dangerous Drug Injury Cases
If you or a loved one have been injured or died as a result of a dangerous drug given with a prescription, from Androgel to Chantix to Xarelto to Zoloft, you need an experienced pharmaceutical liability law firm which is able to stand up for your rights, and seek justice on your behalf. The dangerous drug personal injury lawyers at The Strom Law Firm, LLC are at the forefront of the fight to protect the public, and will stand up for your rights against the big drug and insurance companies. We will fight to ensure that you and your loved ones receive the justice you deserve. Contact our defective drug and wrongful death attorneys at the Strom Law Firm, LLC today for a free consultation to discuss the facts of your case as well as your legal rights. 803.252.4800.