Varenicline safety claims prompt disagreement
Marketing claims that the smoking cessation drug varenicline has a favourable safety profile are ‘questionable' concluded an independent review into the scientific evidence behind the treatment.
The Medicines and Healthcare Products Agency recently warned depression has been reported in patients trying to stop smoking on varenicline and the new review from the Drugs and Therapeutics Bulletin said the reports of psychiatric problems with this drug were ‘concerning'.
The DTB review said: ‘Given such concerns, marketing claims of a "favourable safety and tolerability profile" are questionable,' said the review.
A Pfizer spokesperson said the claim of a favourable profile was justified and was based on trial data referenced in the SPC.