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Shehnaz Bhujwala
Shehnaz Bhujwala
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FDA: Anti-Smoking Drug May Pose Serious Neuropsychiatric Risks to Users

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The Food and Drug Administration issued a public health advisory last Friday to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking. Government regulators believe the connection between Pfizer’s anti-smoking drug Chantix and serious neuropsychiatric problems is “increasingly likely”, warn Chantix may raise the risk of psychiatric disorders and request that the manufacturer of the drug, Pfizer Inc., apply new safety warnings to the medication.

The FDA’s advisory follows an investigation of reports of depression, agitation and suicidal behavior, including at least 37 suicides among patients taking the popular twice-daily pill. Bob Rappaport, director of the FDA’s drug evaluation center, was quoted inThe Washington Post as saying there were “a number of compelling cases that look like they are the result of exposure to the drug itself and not other causes.”

The advisory also emphasized the following safety information for patients, caregivers, and health care professionals:

“Patients should tell their health care provider about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of current psychiatric illness even if it is currently under control. It may also cause an old psychiatric illness to reoccur. FDA notes that patients with these illnesses were not included in the studies conducted for the drug’s approval.

Health care 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 should immediately report changes in mood and behavior to their doctor.

Vivid, unusual, or strange dreams may occur while taking Chantix.

Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.”

Pfizer has reportedly implemented label changes with stronger warnings to the drug. In doing so, the company stressed that a direct link between Chantix and the reported psychiatric problems has not been established, but also could not be ruled out. However, the warnings come too late for families of users who committed suicide while taking the drug. Lawsuits are currently pending against Pfizer for its failure to adequately warn users about the drug’s serious and potentially fatal side effects.