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FDA Drug Safety Podcast for Healthcare Professionals: Safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events

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Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today's topic: Safety review update of Chantix, active ingredient varenicline, and risk of neuropsychiatric adverse events.

Minoo Shafinouri, a pharmacist in the Division will provide you with additional information about this Communication. 

Guest speaker: On October 24, 2011, the Food and Drug Administration issued a Drug Safety Communication alerting the public that FDA has reviewed the results from two FDA-sponsored epidemiological studies that evaluated the risk of neuropsychiatric adverse events associated with the smoking cessation drug Chantix.

Neither study found a difference in risk of neuropsychiatric hospitalizations between Chantix and nicotine replacement therapy, such as NicoDerm patches. However, both studies had a number of study design limitations, including only assessing neuropsychiatric events that resulted in hospitalization, and not having a large enough sample size to detect rare adverse events. Although these two studies did not suggest an increased risk of neuropsychiatric events that result in hospitalization, they do not rule out an increased risk of other neuropsychiatric events with Chantix.

Healthcare professionals and patients should continue to follow the recommendations in the physician label and the patient Medication Guide, and to monitor for neuropsychiatric symptoms when prescribing or using Chantix. Based on FDA's assessment of currently available data, the Agency continues to believe that the drug's benefits outweigh the risks and the current warnings in the Chantix drug label are appropriate.

The risk of serious neuropsychiatric events with Chantix is currently highlighted in the Boxed Warning and Warnings and Precautions section of the physician label and in the patient Medication Guide. Such events can include changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions. These warnings were based on postmarketing reports describing changes in mood and behavior during and after Chantix use.

FDA is continuing to evaluate the risk of neuropsychiatric events with Chantix. The drug manufacturer is conducting a large safety clinical trial of Chantix to assess neuropsychiatric adverse events, and results from this study are expected in 2017.

At this time, FDA recommends that Healthcare Professionals be aware that:

  1. Prescribers should continue to follow the recommendations in the drug label when prescribing Chantix.
  2. Serious neuropsychiatric adverse events, including, but not limited to, depression, suicidal ideation, suicide attempt, and completed suicide, have been reported in patients taking Chantix.
  3. Prescribers should ask patients about any history of psychiatric illness, especially depression, prior to initiating treatment with Chantix.
  4. Patients and caregivers should be advised that the patient should immediately stop taking Chantix and contact a healthcare professional if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior while taking or shortly after discontinuing Chantix.
  5. Patients should be encouraged to read the Medication Guide they receive along with their Chantix prescription.
  6. Adverse events involving Chantix should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. Please read the Drug Safety Communication for the complete Data Summary detailing this communication. A link to this communication can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

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