Depression warnings for Chantix and Zyban
pharmafile | July 7, 2009 | News story | Research and Development, Sales and Marketing |Â Â Chantix, FDA, US, drug safetyÂ
Pfizer and GSK's smoking cessations drugs will have to carry strong warnings of depression and other mental health adverse events after an FDA review.
Pfizers Chantix (varenicline, branded as Champix in the UK) and GSK's Zyban (buproprion) will now carry the strongest possible warnings of possible serious mental health events on their labels.
The FDA decided the products should carry additional warnings after a review of into reported adverse events linked to the drugs, including behavioural change, depression, hostility and suicidal thoughts.
Janet Woodcock, director of the FDA Center for Drug Evaluation and Research said health care professionals prescribing the drugs should monitor their patients for any unusual changes in mood or behaviour after starting the drugs.
She said patients should immediately contact their healthcare professional if they experience such changes.
But she added: "Smoking is the leading cause of preventable disease, disability and death in the United States and we know these products are effective aids in helping people quit."
Pfizer has already updated its product label for Chantix.
Dr Briggs Morrison, senior vice president, primary care development group at Pfizer said the benefits of the drug outweighed the risks for many patients when used as directed.
He added: "The labelling update underscores the important role of healthcare providers in treating smokers attempting to quit."
Chantix has been the subject of regulatory investigation since 2007 after post-marketing reports showed patients had experienced unusual changes in behaviour, depression or thoughts of suicide after taking the drug.
In most cases the problems began shortly after starting the medicine, and ended after ceasing to take the drug.
Launched in 2006, sales of Chantix reached as high as $860 million the following year, but fell back 4% in 2008 after mounting safety concerns.
GSK will also add the warning to buproprion marketed as antidepressant Wellbutrin. Generic versions of the drug will also carry the information.
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Sharp invests $100m in US and EU manufacturing and packaging facilities
Sharp Services, a pharmaceutical packaging and sterile manufacturing specialist, has announced investments totalling $100m across …
Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …
