Drug Injury

Smoking Drug Chantix® Linked to Depression, Suicidal Behavior

The anti-smoking drug Chantix® has been linked to depression, suicidal thoughts, and violent behavior in some users, according to the Food and Drug Administration (FDA) (1). Government scientists are currently investigating the matter after reports of mood disorders and erratic behavior in some users came to their attention earlier this year.

Chantix Update:

According to researchers, hundreds of patients taking Chantix have reported serious accidents, vision problems, and heart trouble.

The FAA then prohibited its pilots from using Chantix because of its possible dangers, which also include blurred vision, dizziness, confusion, loss of consciousness, and a previously established link to suicidal behavior (source).

Chantix is a prescription drug designed to help adults quit smoking. It comes in a white tablet (0.5mg) and a blue tablet (1mg) and is usually taken for 12 weeks at a time (2).

Chantix may be dangerous to some users. The FDA issued a report that stated, “A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion within days to weeks of initiating Chantix treatment(1).” Some of the patients who have been adversely affected by Chantix had no history of psychiatric illness and had not quit smoking when they experienced suicidal thoughts.

Update 1/18/08: Chantix will carry more prominent warnings that patients should be monitored for unusual activity including agitation, depression and suicidal behavior. The new warnings will be featured prominently on the anti-smoking drug’s labeling.

The FDA issued the following alert on 2/1/2008: "FDA is issuing this Alert to highlight important revisions to the WARNINGS and PRECAUTIONS sections of the full prescribing information for Chantix regarding serious neuropsychiatric symptoms. Serious neuropsychiatric symptoms have occurred in patients taking Chantix.

These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking.

In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy."

Our lawyers are committed to helping people affected by Chantix get the legal help they need so that victims can get the compensation they deserve if Chantix use has adversely affected their lives. Call one of our Chantix lawyers today. We want to help.

Chantix® is a registered trademark of Pfizer, Inc. and is used here only to identify the product in question.

Sources:

1. Early Communication About an Ongoing Safety Review Varenicline (marketed as Chantix) from the FDA. Accessed 11/30/07 via www.fda.gov.
2. Patient  Information Sheet—Varenicline (marketed as Chantix) from the FDA. Accessed 11/30/07 via www.fda.gov.

This law firm is not associated with, sponsored by, or affiliated with the Food and Drug Administration or Pfizer, Inc.