On February 1, 2008, the FDA issued a public health advisory regarding Chantix and announced new safety information and warnings to the labeling. The new labeling includes revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced 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.
Chantix (varenicline) is non-nicotine prescription medicine that is approved to help adults quit smoking. Chantix was approved by the FDA in May 2006. Chantix is manufactured and marketed by Pfizer, which began selling the medication in the United States on August 1, 2006.
Chantix is sold as 0.5 mg and 1 mg tablets. The recommended treatment regime calls for a gradual increase in dose with patients taking 0.5 mg every day for 3 days, 0.5 mg twice daily for 4 days, 1 mg twice daily for the remaining 11 weeks The FDA has approved the use of Chantix for twelve weeks, but the treatment regime can be repeated if smoking cessation has not been achieved.
Prior to the revision of the warning label, consumers were not made aware of the risk of behavioral changes associated with the use of this anti-smoking medication. There have also been a number of disturbing reports of suicide attempts by individuals who have used the medication as part of a smoking cessation program.
The FDA is concerned that the use of this medication may be a cause of severe changes in mood and behavior in patients. On February 1, 2008 the FDA highlighted the following related important safety information on Chantix:
* Patients should tell their doctor about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of a current psychiatric illness even if it is currently under control and may cause an old psychiatric illness to reoccur.
* Healthcare professionals, patients, patients’ families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix.
*Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy.
* Patients taking Chantix should immediately report changes in mood and behavior to their doctor.
* Patients taking Chantix may experience vivid, unusual, or strange dreams.
* Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.
The failure to adequately warn consumers and physicians of these risks may be negligence on the part of Pfizer.
If you or a loved one has been injured as a result of using Chantix, then you may be eligible for compensation. Please use our contact form to learn more about your legal rights regarding Chantix. A DrugSettlement.com representative will contact you within 24 hours.
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