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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Varenicline and serious neuropsychiatric symptoms

The Food and Drugs Administration in America has issued a Public Health Advisory that warns of serious neuropsychiatric symptoms associated with treatment.

An on-going review has concluded that, "it appears increasingly likely that there is an association between varenicline and serious neuropsychiatric symptoms".

Patients and their carers have been warned to:

  • Tell their doctor about any history of psychiatric illness prior to starting treatment with varenicline
  • Be alert to and monitor for changes in mood and behaviour including anxiety, nervousness, tension, depressed mood and thinking about or attempting suicide
  • Immediately report changes in mood and behaviour to their doctor and stop treatment
  • Be aware that varenicline may cause vivid or strange dreams and may impair the ability to drive or operate heavy machinery

Action: Clinicians should be aware of these safety concerns. Treatment should be stopped immediately if a patient develops neuropsychiatric symptoms. Clinicians should also be aware that these symptoms have developed in some patients after treatment was stopped.

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