The FDA announced yesterday that the makers of the stop-smoking drugs Chantix and Zyban are being required to put information about the risk of behavior changes, depression, hostility and suicidal thoughts in a black box on the warning label, which is the strongest warning that can be placed on a prescription medication.

>>FDA ANNOUNCEMENT: Zyban and Chantix Black Box Warning

For over 18 months, the lawyers at Saiontz & Kirk, P.A. have been investigating potential Chantix suicide lawsuits, alleging that Pfizer failed to adequately warn about these problems. After receiving hundreds of reports involving users who suffered severe or fatal injuries from a suicide attempt on Chantix, the FDA is finally requiring Pfizer to take stronger steps to ensure that people are aware of the risk.

The FDA first indicated that they were reviewing the side effects of Chantix in November 2007. In response, Pfizer updated the drug’s label, but provided vague and confusing indications about a connection between Chantix and suicide, suicidal thoughts and other changes in behavior. Since that time the drug maker has made several other updates to the warning label, but the FDA’s actions yesterday make it clear that Pfizer has not done enough to protect the public from the Chantix dangers.

While we have suggested before that a Chantix recall may be necessary, since the risk of suicides and other life-threatening side effects seems to outweigh the minimal benefits that the drug provides over other methods that people can use to stop smoking, Chantix will remain on the market. The FDA suggested that with the stronger warnings, consumers and their doctors will be able to weigh the risk of Chantix side effects against the benefits.

In addition to Chantix, the warning will also be placed on Zyban, another prescription drug for smoking cessation. According to an FDA statement released Wednesday:

The FDA’s request for the additional warnings is based on a review of reports submitted to the agency’s Adverse Event Reporting System since the time the products were marketed and on an analysis of information from clinical trials and scientific literature.

The analyses revealed that some who have taken Chantix and Zyban have reported experiencing unusual changes in behavior, become depressed, or had their depression worsen, and had thoughts of suicide or dying. In many cases, the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped.


Pfizer’s failure to properly research their medication and warn about the Chantix suicide problems when they first placed the drug on the market in 2006, prevented consumers and health care providers from making an informed decision about whether to take the drug. In addition, many consumers who suffered severe or fatal injuries in a suicide or suicide attempt could have contacted their doctors or sought help if they had been notified that the drug may be responsible for their sudden changes in behavior.

The Chantix attorneys at Saiontz & Kirk, P.A. are continuing to review potential cases for individuals throughout the United States. In addition to cases for injuries or death caused by a suicide or suicide attempt on Chantix, lawsuits are also being investigated for new on-onset diabetes from Chantix, serious skin reactions like Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis and accidents or falls caused by seizures, blackouts or other sudden problems.

If you, a friend or family member have a potential Chantix lawsuit, contact our attorneys and request a free consultation and claim evaluation.