The United States Food and Drug Administration (FDA) has initiated a second safety review of Pfizer’s smoking cessation drug Chantix. An earlier review by the agency in February linked the drug to serious neuropsychiatric symptoms, at which time the FDA requested Pfizer elevate the prominence of the safety information to Chantix’s prescribing information and label.

The decision for a second review comes less than one month after a report by the Institute for Safe Medication Practices warned Chantix patients could experience a lapse in alertness or motor control, which could lead to massive, serious injury, especially in patients who operate aircraft, trains, buses and other vehicles.

Following the release of this report, the Federal Aviation Administration (FAA) and the Federal Motor Carrier Safety Administration (FMCSA) decided to change their stances on employees’ use of Chantix.

Source: Anna Boys, “FDA to run a safety review on Chantix,” EFluxMedia, June 2, 2008.