Chantix Warnings - Consumer Justice Foundation

Chantix Warnings

Written by Faith Anderson on December 14, 2012
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Side Effects Potentially Connected to Chantix

Chantix (or generic varenicline) is a prescription drug used to help adults quit smoking by blocking the effects of nicotine on the brain. The FDA first notified consumers about a possible increased risk of heart side effects with Chantix use in its June 2011 Drug Safety Communication. The agency then required Chantix maker, Pfizer, to conduct the meta-analysis in an effort to further evaluate the cardiovascular safety of the drug, and believes it is imperative that patients and medical professionals are aware of the results of the Chantix study. The Warnings and Precautions section of the Chantix drug label has been updated to reflect the results of the revealing meta-analysis.

Federal Agencies Ban Chantix Use

In addition to adverse cardiovascular events, other side effects potentially linked to Chantix were first brought to light back in 2007, only one year after Chantix was approved, and may include irregular heartbeat, seizures, blackouts, and possibly even psychiatric complications like aggression and suicide. In light of these risks, the FDA ordered pilots with the Federal Aviation Administration (FAA) to stop taking Chantix the following year, and the Federal Motor Carrier Safety Administration issued a similar ban for its commercial truck and bus drivers shortly thereafter. Furthermore, the Department of Defense prohibited certain weapons and aircraft personnel from using Chantix to avoid the risk of devastating consequences related to potential Chantix side effects.

Alleged Risks of Chantix Should be Weighed Against Benefits

In light of this new information, healthcare professionals have been advised to weigh the risks of Chantix against the possible smoking cessation benefits of the medication. The FDA recommends that patients taking Chantix who experience new or worsening symptoms of cardiovascular disease – such as shortness of breath; chest pain; calf pain when walking; or sudden onset of numbness, weakness or difficulty speaking – should contact their physician immediately. Patients should also seek medical attention if they have any questions or concerns about taking Chantix to quit smoking. Any side effects potentially linked to the smoking cessation drug should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

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