Over the past year the reports of adverse reactions to Pfizer’s smoking cessation drug Chantix have been mounting at a furious pace. After an analysis of the adverse events associated with Chantix, Dallas’ CBS11 concluded that over the first nine months of 2007 the number of adverse events associated with drug drastically increased. The number rose from just shy of 700 in the first three months to 3,700 at the end of nine months. Reports of suicidal thoughts were shown by the data to double every three months over the timeframe. The number of suicide attempts increased at an even greater rate, from zero in the first three months to 18 by the end of September. Now a consumer watchdog group is calling for the FDA to require their strongest warning, the “black-box” warning, to be added to the Chantix label.
Public Citizen, a group founded by Ralph Nader, feels the FDA should order the drug manufacturer, Pfizer, to put this stronger labeling on the medicine to warn of serious side effects like depression and suicidal thoughts that may be associated with the drug.
In January Pfizer did update the label to include a warning that all patients taking the drug should be monitored for neuropsychiatric events, including suicidal thoughts and suicidal behavior. The label was also modified to include these issues in the EU in the month of February.
The Public Citizen does not believe the updated label provides an adequate warning for the dangers associated with Chantix. It is not clear how the FDA will respond to the request, but Dr. Wolfe of the Public Citizen said that the group is successful on about two out of every three warning request to the FDA.