FDA Employs Full Tool Box to Monitor Chantix

Washington, DCThe horrific incidents involving attempted or successful Chantix suicide among other side effects prompted the US Food and Drug Administration (FDA) to require a post-approval risk evaluation and mitigation strategy (REMS), according to the October 8th issue of the Food and Drug Letter.

Chantix—a smoking cessation drug—came to the market in 2006 amidst much fanfare. It was hailed at the time as a magic bullet of sorts for the smoker haunted by a history of failed attempts to quit.

It came as somewhat of a surprise, then, that a rash of Chantix side effects began to appear—and some quite disturbing. By 2007 the FDA reported receiving thousands of post-market reports of severe changes in behavior, agitation and depressed mood. Patients were reporting vivid nightmares, and adverse events included disturbed heart rhythm and vision problems.

Most serious were the incidents of attempted and completed suicide. The FDA reported no fewer than 78 deaths; with 28 from suicide in the US alone.

It was for this reason that the FDA, according to the October 8th report, issued an early communication about Chantix and urged manufacturer Pfizer to add the risks for suicide and behavioral changes to the product labeling. A black box warning was forthcoming.

Among other precautions, which included a drug safety alert issued by the FDA in early 2008, was the implementation of a REMS in tandem with a communication plan intended to ensure that those most in need of vital information pertaining to Chantix were, indeed, properly informed.

The REMS serves as a template for the manufacturer to facilitate the dissemination of information to the FDA and others according to a set list of goals and timetables for response. Through the REMS supporting documents, the FDA seeks information about the background of the product—in this case, Chantix—as well as the goals outlined for the REMS, the potential elements, the means by which they are assessed and any other relevant data.

While the REMS is not made public, it does provide the FDA with tools to monitor a product under scrutiny in an advanced and thorough fashion.

There is reason for such thoroughness and other related Chantix warnings. By mid 2007 the Institute for Safe Medication Practices reportedly ranked Chantix as the drug with the third-highest number of serious adverse events in the entire US. Those adverse events included, but are not limited to, Chantix and suicide, and Chantix aggression.