Pfizer failed to adequately alert federal authorities for several years about more than half of the suicides suspected of being related to its anti-smoking drug Chantix, according to a report by a nonprofit watchdog group.

The analysis by the Institute for Safe Medication Practices found that Pfizer did not submit 589 cases of serious psychiatric effects, including 150 suicides, through the electronic system intended to bring such incidents to the prompt attention of the Food and Drug Administration.

The report found that the failure to quickly report those suicides and other serious psychiatric problems to the FDA’s adverse event reporting system occurred from 2007 through July 2010 , when the agency took up the issue with the company. Chantix, or varenicline, was approved by the FDA in 2006.

Instead, as reports, Pfizer lumped together its reports on the serious events in which Chantix was “the primary suspect drug” with 26,000 records the company submitted on non-serious side effects such as nausea and rashes. As such, the serious incidents were included amid batches of paper documents that are less closely monitored and less frequently checked.

“The risks of serious psychiatric side effects were previously underestimated because so many of these events were not promptly reported, and were therefore omitted from the FDA’s safety analysis,” the institute’s report said.

The institute called on the FDA to investigate “why 150 completed suicides and scores of suicide attempts were not reported promptly to the AERS safety monitoring system,” and it said the agency’s safety assessment of the smoking cessation drug should be revised. “We believe this drug is unsafe for widespread clinical use,” the institute said.

In the past, the FDA has stated that there is a “risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts,” among patients taking Chantix. In response to the institute’s report, the agency said in a statement it “does not have any new safety concerns with Chantix, though those that have been established remain under active review.”

FDA officials said they are continuing to review Chantix in clinical trials and in two large observational studies with the Veterans Administration and the Department of Defense.

For its part, Pfizer, the world’s largest drug company, said it followed the FDA’s rules and changed its reporting practices after the agency raised the issue last year.

The institute says that the number of suicides associated with Chantix, including the 150 cited in its analysis, now stands at 272.

In December, 2010, FairWarning reported that Pfizer had failed in clinical trials to test the drug on mentally ill smokers, despite the fact that a disproportionate number of smokers suffer from some form of psychiatric illness and are a key part of the target market for smoking cessation treatments.

According to, some 1,545 lawsuits over the drug have been filed in federal court. One recent suit alleges the drug caused Sean Wain, 34, of Economy, Pa., to kill his wife Natalie, 33, and himself in May, 2009, leaving four children behind.

Separately, France’s health ministry has decided to stop providing insurance coverage for Chantix or, as it is known there, Champix, because of continued concerns over the drug, Reuters reports.


With Pfizer, FDA Shunning Tests on Mentally Ill, Promise of Smoking Remedy Chantix Turns to Ashes for Some