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FDA boxed warnings for Chantix and Zyban

The US FDA has announced a requirement for manufacturers to put a boxed warning on the prescribing information for Chantix and Zyban

The US Food and Drug Administration (FDA) has announced a requirement for Pfizer and GlaxoSmithKline to put a boxed warning on the prescribing information for their smoking cessation drugs Chantix (Champix in Europe) and Zyban respectively.

The warning is required in order to highlight the possibility of serious mental health issues such as depression, hostility and suicidal thoughts while taking the drugs. The FDA is also asking manufacturers to include more information in the warnings section of the prescribing information and to update the content in the medication guide for patients.

An analysis of reports submitted to the FDA's Adverse Event Reporting System, revealed that some patients taking Pfizer's Chantix or GSK's Zyban have experienced unusual changes in behaviour, depression and thoughts of suicide or dying. In many cases the occurrence of the symptoms coincided with starting and ending treatment with one of the drugs mentioned. In some cases, the symptoms continued after medication was stopped and, in a few, the symptoms only began after the treatment finished.

"The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking," said Dr Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "Smoking is the leading cause of preventable disease, disability, and death in the US and we know these products are effective aids in helping people quit."

The manufacturers will also be required to carry out clinical trials to determine the frequency of serious neuropsychiatric symptoms in patients using various smoking cessation products. Studies will need to include patients who currently have psychiatric disorders.

Some of the symptoms experienced by patients using Chantix and Zyban may have been the result of nicotine withdrawal as nicotine is not present in either drug. However, some patients reported adverse symptoms while using the drugs and continuing to smoke.

Pfizer has responded to the FDA's request by updating the product labelling for Chantix immediately including letters to doctors and pharmacists and amendments to websites.

"The labelling update underscores the important role of healthcare providers in treating smokers attempting to quit and provides specific information about Chantix and instructions that physicians and patients should follow closely," said Dr Briggs W Morrison, senior vice president, Primary Care Development Group at Pfizer.

2nd July 2009

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