Advocacy Groups Call for Better Chantix Warning Labels

Although Personal Injury Lawsuits Settled, Consumer Advocates Insist Chantix Warning Labels Need Updating

Chantix warning labelsAlthough the pharmaceutical company settled numerous personal injury lawsuits last year involving psychiatric problems linked to the drug, public safety advocates have requested that the federal government strengthen Chantix warning label, Pfizer’s antismoking drug.

Even as these consumer advocacy groups call for stronger labels, Pfizer has written a letter to the FDA requesting the removal of such warnings. Currently, the Chantix warning label contains bold letters on Chantix boxes warning consumers about potential psychiatric side effects from the prescription anti-smoking medication. At the end of September, the FDA agreed with Pfizer to update the Chantix warning label, indicating that the drug may not carry the risks of suicidal behavior that prompted the stern warning in 2009. Pfizer included a meta-analysis of five major studies involving nearly 2,000 patients who, according to Pfizer, did not show an increase in depression or suicidal thoughts while taking Chantix.

“It is unusual for the FDA to consider withdrawing a [Black Box] warning,” the most serious type of warning in product labeling, Thomas Moore, a senior scientist at the Institute for Safe Medication Practices, writes to us. “It also raises the question of what compelling scientific evidence is required for this unusual action.”

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.

“The court adjudicated a number of dispositive motions, including Daubert motions with respect to whether the use of Chantix can cause serious neuropsychiatric events and whether the current Chantix label is adequate as a matter of law,” the judge ruled.

Five consumer groups, however, have 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.

“It was not until July 2010 that the FDA learned that Pfizer had failed to properly submit 26,000 adverse event reports, including 589 serious cases, 150 completed suicides, 102 cases of hostility/aggression, and 56 cases of psychosis. In addition, later peer reviewed studies provide important new insights into cases involving aggression/violence, as well as comparisons with other smoking cessation treatments.”

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.


Share on facebook
Share on twitter
Share on linkedin

Follow us

Sign Up For Our Newsletter!