Varenicline May Be Linked to Risk for Serious Neuropsychiatric Symptoms
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February 2, 2008 — The prescribing information for varenicline tablets (Chantix, Pfizer, Inc) has been updated to include warnings about the risk for serious neuropsychiatric symptoms, the US Food and Drug Administration (FDA) announced yesterday in a public health advisory.
The changes follow an early communication from the agency in November 2007 that advised healthcare professionals and the public regarding postmarketing cases of new-onset depressed mood, suicidal ideation, and behavioral/emotional changes within days to weeks of starting varenicline therapy. At that time, the causal role of varenicline remained unclear.
However, new information from an ongoing FDA analysis increasingly suggests that a link exists between varenicline and reports of behavioral changes, agitation, depressed mood, suicidal ideation, and attempted and completed suicide.
Although some of these events may have occurred in association with nicotine withdrawal, other patients had not yet discontinued smoking, according to an alert issued by MedWatch, the FDA’s safety information and adverse event reporting program. Most cases occurred during treatment, but some also were reported following withdrawal of varenicline therapy.
"Chantix has proven to be effective in smokers motivated to quit, but patients and healthcare professionals need the latest safety information to make an informed decision regarding whether or not to use this product," says Bob Rappaport, MD, director of the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products, in an FDA news release.
"While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert the public about these risks. Patients should talk with their doctors about this new information and [about] whether Chantix is the right drug for them, and healthcare professionals should closely monitor patients for behavior and mood changes if they are taking this drug," Dr. Rappaport adds.
Because varenicline may cause worsening of current psychiatric illness (even if it is under control) and cause recurrence of prior illness, patients should inform their healthcare provider of any such illness before initiating varenicline therapy.
Patients and their families/caregivers should be alert to changes in mood or behavior during treatment with varenicline; these should be immediately reported to a healthcare provider. The FDA also warns that vivid, unusual, or strange dreams may occur during therapy and that patients may experience impairment of their ability to drive or operate heavy machinery.
At present, the FDA is working with the manufacturer to finalize a medication guide for patients. Further safety labeling changes may be warranted as the FDA continues its review of data and of new information regarding varenicline and the risk for severe changes in mood and behavior.
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