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Published on Jan 22, 2008 by Edgar Snyder

Anti-Smoking Drug Chantix Banned by FAA

Chantix

May 21 2008 UPDATEThe anti-smoking drug Chantix has received another blow – the Federal Aviation Administration has removed the potentially dangerous drug from the list of medications considered safe for pilots. A new study has linked the medication to bad reactions such as mental confusion that can put passengers at risk.

The Chantix safety study also links the drug to side effects like loss of consciousness, lapses in alertness, dizziness, and muscle spasms. The study was published online by the Institute for Safe Medication Practices. The authors of the study found the results too important to wait months for publication in a medical journal.

Chantix was approved by the Food and Drug Administration (FDA) in May 2006, and 3.5 million people in the United States have taken the drug since that time. Chantix has been under scrutiny since 2007 when the FDA began investigating its link to erratic behavior. As new health and safety problems associated with the drug have emerged, its label has been updated and the FDA has issued alerts about the medicine's negative side effects.


Feb 2008 UPDATE – The U.S. Food and Drug Administration (FDA) has reported that the link between Pfizer’s anti-smoking drug Chantix and serious psychiatric problems in users of the drug is “increasingly likely.” The FDA has received reports of 37 suicides and more than 400 instances of suicidal behavior in connection with the medication.

This comes two weeks after Pfizer added stronger warning labels to Chantix. At the time, Pfizer said that instances of suicidal behavior could be linked to the effects of nicotine withdrawal and not the drug itself. However, the FDA reports that psychiatric problems have been found in Chantix patients who are still smoking, strengthening the causal link between the drug and suicidal behavior.

In a public advisory released Friday, February 1, the FDA said patients taking Chantix should tell their doctor about any history of mental illness. Additionally, family members and friends should look for any changes in mood or behavior.


Jan 2008 ORIGINAL ALERT – Trying to quit smoking? Be aware that Pfizer, Inc. has issued stronger warnings about its anti-smoking drug Chantix. Instances of depression, agitation, suicidal thinking, and suicidal behavior have been reported among some users of Chantix, and doctors are being asked to closely monitor this behavior.

The serious nature of these side effects has prompted Pfizer to strengthen the language of a previous warning and feature it more prominently on the drug’s label. The U.S. Food and Drug Administration has been reviewing the safety of Chantix since last November.

Chantix is used by more than five million patients. The drug first came under widespread public scrutiny after family members of a prominent Dallas musician claimed Chantix may have caused the rage that led him to be shot and killed after kicking down a neighbor’s door.

Please note: All of our lawyers are licensed to practice in the state of Pennsylvania. We also have lawyers licensed to practice in Maryland, Ohio, Virginia, and West Virginia, and we associate with experienced attorneys in other states. In addition, all drug-related litigation may involve co-counsel.

Sources:
"Pfizer Strengthens Warnings on Chantix." Associated Press. January 18, 2008.
"Pfizer Heightens Chantix Warning." The Wall Street Journal. January 18, 2008.
"FDA Warns of Anti-Smoking Drug Risks." ThePittsburghChannel.com. February 1, 2008.
"FAA bans anti-smoking drug Chantix." USA Today. May 21, 2008.
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