Chantix Side Effects
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Chantix Side Effects
Chantix is a medication designed to help smokers break the habit. It was developed and is produced by Pfizer, who received FDA approval to put the product on the market as a prescription drug in May of 2006. The clinical trials for Chantix showed frequent instances of side effects such as nausea, insomnia and abnormal dreams. During its introductory phase on the commercial market, Chantix did prove to help smokers quit, including those who had tried many other methods and failed.
However other disturbing evidence began to surface about side effects with Chantix that went beyond 'abnormal dreams'. With alarming frequency, Chantrix users were having problems with mood swings, erratic behavior and worse, both thoughts of and attempts at suicide.
By February of 2007 the FDA had seen enough reports of psychiatric difficulties associated with the drug to issue a Public Health Advisory. This formal notification to the medical community and consumers stated that "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."
The FDA has degrees of importance that it assigns to the standard warnings issued with any approved medication. As a result of the data reported in February 2007, Pfizer was asked to elevate the packaged warning about psychiatric dangers associated with Chantix to the Warnings and Precautions portion of the information sheet distributed with every prescription of Chantix.
While many patients in the clinical trials (30%) had reported problems with nausea, the psychiatric impact of the drug has become a major issue in the year following the FDA’s initial warning. On February 1st of 2008 the FDA issued an additional warning about the connection between Chantix and psychiatric difficulties among users.
While there is a case to be made that erratic and unpleasant behavior may also be connected to nicotine withdrawal, Chantix was designed to minimize the physical cravings for smokers. Moreover, patients who were continuing to smoke while using Chantix were some of the individuals who had reported – or exhibited – severe psychiatric abnormality.
The most recent warning from the FDA says that, "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." The FDA notes that it is working with Pfizer on a "Medication Guide for patients."
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