FDA warns of increased risk of committing suicide on Chantix

By Harvey Kirk
Posted February 4, 2008

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On Friday, the FDA issued an alert highlighting important changes made to the Warnings and Precautions section of the Chantix label. Psychiatric symptoms, such as severe changes in mood and behavior, have been associated with the antismoking drug. There have been numerous reports of individuals who committed suicide on Chantix, or suffered serious physical injury a a result of suicide attempts. The Chantix lawyers at Saiontz & Kirk, P.A. are reviewing potential claims throughout the United States for users of the drug who have been injured.

>>INFORMATION: Chantix Lawsuits

Chantix is a popular pill which is taken twice daily to help people quit smoking. It works by reducing symptoms of nicotine withdrawal and binding to receptors in the brain which react favorably to nicotine. The medication has been effective in helping many people quit smoking, often with long-term success. However, many question whether the benefits of taking Chantix to stop smoking are outweighed by the risks associated with the drug.

In November 2007, the FDA issued an “Early Communication” about an on-going review into the risk of users committing suicide on Chantix. The drug regulators have reviewed reports which included 39 deaths from suicide while taking Chantix and nearly 500 reports of suicidal thoughts and behavior.

At the time the FDA began their review, Pfizer, the manufacturer of Chantix, was not providing any warnings to users or indications to doctors about the potential increased risk of suicidal thoughts or behavior associated with the use of Chantix. After the “Early Communication” was issued, they did add information to a less prominent section of the label. However, many people found the reference confusing, and conflicting information diminished the warning.

Although the FDA’a review continues, the Alert was issued to report that their evaluation indicates it is “increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The FDA also released the statement to highlight a strengthening of the Chantix label which Pfizer announced two weeks ago. The new label will include stronger language and the information about possible suicide, suicidal thoughts and behavioral changes will be moved to a more prominent section.

>>PRIOR POST (1/25/08): Chantix Suicide Warning Strengthened by Pfizer

The FDA is also requiring Pfizer to develop a medication guide which will be given to individuals taking Chantix, since many do not read or understand the warning labels. The information guide will highlight the warnings about serious psychiatric symptoms and the possible risk of committing suicide on Chantix. Doctors have also been asked to make sure they find out about any history of mental illness before prescribing Chantix and make sure that those taking the drug, as well as their family members, are aware of the possible side effects so that they can watch for signs of behavior changes, depression or suicidal thoughts.

LAWSUITS FOR SUICIDE ON CHANTIX

It is important to provide complete information about the risk of suicide to individuals who are trying to decide whether to use Chantix to help them quit smoking or to try to stop on their own. Without adequate warnings and information, potential users are deprived of the opportunity to decide for themselves whether they are willing to accept the risk of suicide on Chantix.

If you, a friend or family member have suffered serious physical injury or death as a result of suicide on Chantix, request a free case evaluation.