The Food and Drug Administration (FDA) ordered Pfizer Inc and GlaxoSmithKline PLC to add strong warnings on their anti-smoking drugs to highlight the risk of serious mental health problems, including suicidal thoughts.

The warnings, which must be added to Pfizer’s Chantix and Glaxo’s Zyban, follow more than five thousand reports of depression, hostility and other behavioural changes, the FDA said.
FDA officials said there was still a need for the medications, their concerns tempered by smoking’s health dangers, such as lung cancer and heart disease. “We don’t want to scare people off from trying to use the medication to stop smoking. We just want them carefully monitored,” said Dr. Curt Rosebraugh, who oversees the FDA office that reviews smoking-cessation drugs.
The warnings will limit Pfizer’s ability to run some types of advertisements for Chantix.
The FDA is also requiring the companies to conduct additional clinical trials to help determine how serious a problem the mood disorders are, including among patients who already have depression or other similar conditions.
The FDA first alerted patients and doctors about possible mood changes with Chantix in November 2007, and has continued to receive reports of problems. Overall, the agency received 4,762 reports of serious psychiatric events since Chantix’s 2006 approval. For Zyban and its generic rivals, it received a total 527 reports, it said. Specifically, the FDA said it received 98 reports of suicide and 188 reports of attempted suicide with Chantix and 14 reports of suicide and 17 attempts with Zyban and related generics. (pi)