Pfizer’s Anti-smoking Drug Could Lead to Psychiatric Symptoms - FDA
Chantix, approved by the FDA in May 2006 and as Champix by Health Canada a year ago, acts on sites in the brain affected by nicotine. The drug helps ease
withdrawal symptoms and blocks the effects of nicotine if users resume smoking.
But Friday FDA issued a public health warning saying it wa linked to potentially serious neuropsychiatric symptoms.
Patients taking the smoking cessation aid should be on the lookout for any changes in mood and behaviour, as should their families and health providers, said the advisory.
Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviours and thinking about or attempting suicide.
In most cases, neuropsychiatric symptoms developed during treatment with the drug, but in others, symptoms developed following withdrawal of therapy.
The FDA said patients should tell their doctors about any history of psychiatric illness prior to starting the drug, as it might worsen the condition even if it is currently under control. It may also cause an old psychiatric illness to recur.
The agency noted that patients with psychiatric illnesses were not included in the studies conducted for the drug’s approval.
“Chantix has proven to be effective in smokers motivated to quit, but patients and health-care professionals need the latest safety information to make an informed decision regarding whether or not to use this product,” Dr. Bob Rappaport, director of the FDA’s division of anesthesia, analgesia and rheumatology products, said in an advisory.
Filed under: Pharmacy News
Leave a Reply
You must be logged in to post a comment.