Chantix Lawsuit News: Will Recent Reports Compel An FDA Recall?

Branden Samuels | May 27th, 2011

In light of recent developments highlighting severe Chantix side effects and poor FDA compliance by Pfizer, the question of whether or not there will be a Chantix recall is more relevant than ever.

A Chantix recall could affect millions of Americans who are now taking the smoking cessation aid to curb cigarette cravings and help them quit smoking for good.

Chantix side effects adverse events

The FDA is currently monitoring a flood of adverse event reports linked to Chantix. Reported side effects include mood swings, aggressive behavior, violence depression and suicide.

Earlier this month it was revealed that Pfizer, which manufactures Chantix, had improperly filed hundreds of adverse events, thus keeping the FDA from properly analyzing the impact of the drug on American health.

Chantix side effects reporting was not complete

According to the Institute for Safe Medication Practices (ISMP), a nonprofit consumer health watchdog, Pfizer compensated for earlier lapses in reporting by submitting 1,055 serious adverse events reports (AERs) to the FDA in the third quarter of 2010. More than half of those adverse events occurred in years prior, according to the ISMP.

Of the 1,055 serious adverse events, 150 were Chantix suicides. Prior to last year’s third quarter, Pfizer had reported just 37 Chantix suicides to the FDA. Consumers and doctors had submitted 85.

News of Pfizer’s improper AER filings comes as a Pittsburgh area family has filed suit against Pfizer after Chantix allegedly caused a murder-suicide that has left 4 minors without parents.

Chantix murder-suicide claimed

Sean M. Wain reportedly began taking Chantix in 2009, one-to-two weeks before killing his wife and then himself. On May 9, 2011, the parents of Wain and his wife filed a wrongful death lawsuit, claiming Pfizer misrepresented “the dangers and risks of injuries associated with the use of Chantix, including serious injury and death.”

The Wain lawsuit is one of more than 1,200 Chantix lawsuits consolidated in an Alabama federal court. Chantix lawsuit news experts say the first lawsuit could go to trial in early 2012.

Chantix recall?

Still, the question remains whether mounting Chantix side effects reports will push the FDA to issue a Chantix recall. Typically, the FDA doesn’t request a drug recall unless new evidence pushes a drug’s risk-benefit profile to the point where the drug is more harmful than helpful. Calculating such a risk is a complicated and process that can take years.

Other options to a Chantix recall

The FDA may opt for a less drastic regulatory measure than an all out Chantix recall. The administration could strengthen the drug’s warning label, censure Pfizer for poor compliance, or institute a program that thoroughly vets potential Chantix users to make sure those who may be most susceptible to Chantix side effects such as depression and Chantix suicide aren’t prescribed the drug.

Chantix was approved by the FDA in 2006. Five years later, we may still be in just the formative years of the drug’s history of regulation.