Chantix®

Injury Lawyers Serving Virginia, Maryland and Washington D.C.

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, 3).

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 Linked to Psychiatric Problems, Black Box Warning Added:

From the FDA:

"The FDA is notifying the public that the use of Chantix (varenicline) or Zyban (bupropion hydrochloride), two prescription medicines that are used as part of smoking cessation programs, has been associated with reports of changes in behavior such as hostility, agitation, depressed mood, and suicidal thoughts or actions. 

The FDA is requiring the manufacturers of these products, including generic versions of Zyban (bupropion), to add a new Boxed Warning to the product labeling to alert healthcare professionals to this important new safety information.

People who are taking Chantix or Zyban and experience any serious and unusual changes in mood or behavior or who feel like hurting themselves or someone else should stop taking the medicine and call their healthcare professional right away. Friends or family members who notice these changes in behavior in someone who is taking Chantix or Zyban for smoking cessation should tell the person their concerns and recommend that he or she stop taking the drug and call a healthcare professional right away."

The Federal Aviation Administration (FAA) has 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).

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."

September 2009 Update:

The FDA stated, “The FDA's analysis of adverse event reports shows that when neuropsychiatric symptoms occur, they usually develop during drug treatment, but symptoms can also develop after the drug is stopped. 

Some patients on these drugs who had no history of psychiatric illness experienced suicidal ideation and behavior for the first time. The drugs have also been associated with a worsening of symptoms in patients with pre-existing psychiatric disorders (4).”

We Want to Help

Our drug injury 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.
3. FDA Public Health Advisory from the FDA. Accessed 7/6/09 via www.fda.gov.
4. Warning on Neuropsychiatric Effects from Smoking Cessation Drugs from the FDA. Accessed 9/2/2009 via www.fda.gov. 

 

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

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