Chantix Side Effects Face New FDA Review

Federal drug officials plan to take a second look at the potential psychological side effects of Chantix, and may be preparing to back off of prior warnings that indicated the smoking cessation drug may cause violent behavior and suicidal tendencies.  

On Friday, the FDA announced that it will hold a public meeting in October to re-examine the potential effects of Pfizer’s stop smoking drug. The meeting comes after some studies have raised questions over whether prior warnings about the risk of suicide from Chantix are warranted.

Pfizer officials say they have new data and are proposing an update to the drug’s label warnings that they hope the FDA will implement. The meeting is set for FDA’s White Oak Campus in Silver Spring, Maryland, on October 16 at a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

While recommendations issued by FDA advisory committees are not binding, the FDA usually follows the guidance.

Chantix Physiological Warnings

Chantix (varenicline) was approved by the FDA in 2006 as a prescription medication to help people quit smoking. The drug works by reducing the positive feelings that come from cigarettes, blocking the receptors in the brain commonly stimulated by nicotine. However, a few years after the drug was introduced and heralded as a potential blockbuster medication, reports began to surface of users committing suicide or engaging in sudden, unusual behavior.

In 2009, the FDA ordered that a black box warning be placed on the drug, due to the psychological side effects. The warning is the strongest label requirement the FDA can order a drug to carry.

Following the black box warning, Pfizer was hit with thousands of Chantix lawsuits brought on behalf of former users who suffered physical injuries or death following a suicide attempt or other unusual, aggressive behavior while taking the drug. Pfizer has settled most of the Chantix suicide cases for about $300 million.

A study published by the Annals of Internal Medicine in September 2013 found that smokers taking Chantix were able to quit smoking without increasing their depression. The researchers found that users may not face suicidal thoughts either.