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Article: US FDA issues warning on Pfizer's Chantix.
- Article from:
- Pharma Marketletter
- Article date:
- November 26, 2007
CopyrightCOPYRIGHT 2007 Marketletter Publications Ltd. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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The US Food and Drug Administration has issued an early communication about an ongoing safety review of world drug major Pfizer's smoking-cessation drug Chantix (varenicline) after reports of suicidal thoughts and erratic behavior. The FDA says it has updated the product label to include reports of psychiatric side effects in Chantix patients, but stressed that it has not yet concluded whether they were caused by the drug.
On its web site, the FDA stated that it is aware of a highly-publicized case of erratic behavior leading to the death of a patient using Chantix to attempt to quit smoking. Although other factors, including alcohol consumption, appear to have ...