New research indicates Pfizer’s stop-smoking drug Champix may not increase the risk of depression and heart attacks as previously thought.
The study, published in The Lancet Respiratory Medicine, followed over 160,000 patients for five years who received nicotine replacement therapy (NRT), GlaxoSmithKline’s anti-smoking drug Zyban (bupropion) or Pfizer’s Champix (varenicline).
The researchers found that people taking either Champix or Zyban were no more likely to suffer a heart attack or develop depressive symptoms than those on NRT.
Additionally, use of Champix was associated with a significantly reduced risk of ischaemic heart disease, cerebral infarction, heart failure, arrhythmia and depression.
Aziz Sheikh, one of the study’s researchers and co-director of the University of Edinburgh’s Centre for Medical Informatics, said: “On the basis of our extensive analysis, we believe it is highly unlikely that varenicline has any significant adverse effects on cardiac or mental health.
“Regulators such as the Food and Drug Administration (FDA) should review their safety warning in relation to Champix as this may be unnecessarily limiting access to this effecting smoking cessation aid.”
The results come as good news for Pfizer, which is already undertaking a very similar study evaluating neuropsychiatric safety, the results for which will be available later this year.
Champix, marketed as Chantix in the US, achieved global sales of $647m in 2014 making it one of the highest-selling smoking cessation drugs.
However, since the controversy surrounding the drug’s side effects, sales have fallen from 2007, when it brought in $883m.
Since 2008, the drug has been at the centre of nearly 3,000 lawsuits, however, all the cases were settled by Pfizer in June 2013.