Product News and Recalls

FDA Advises Leaving Black Box Warning on Pfizer’s Chantix

The United States Food and Drug Administration decided to maintain the black box warning on Pfizer’s smoking cessation drug Chantix (varenicline). The drug continues to carry the very serious black box warning which was first added to the label in 2009.

In seeking the removal of the black box warning, Pfizer relied on a meta-analysis of five studies to argue there is no association between the drug and suicidal thoughts. The advisory panel nonetheless is requiring further studies be completed before recommending a label change. This is bad news for Pfizer whose sales of Chantix plummeted from $846 million in 2008 to $648 million in 2013. In addition, lawsuits over Chantix have cost the company hundreds of millions of dollars.

Meanwhile, Pfizer is facing thousands of lawsuits by women who say their anti-cholesterol drug, Lipitor, caused them to develop diabetes while the warnings associated with that drug were inadequate.

Black box warnings are reserved for the FDA’s sternest of cautions. Drugs that pose serious hazards receive such warnings in order to draw attention to the potential adverse effects. Lipitor currently carries no warning specifically regarding diabetes, even though at least one similar statin does.

Chantix has previously been linked with severe neuropsychological effects. The 2009 warning mentions suicide, hostility, and depression as possible adverse effects. In reviewing the current Chantix black box label, only one committee member voted in favor of removal. Others voted to maintain the label and some even voted for a stronger warning.

While Lopez McHugh lawyers were successful in a number of Chantix cases, the deadlines for filing those claims have largely expired. Currently, the Lipitor lawyers at Lopez McHugh are actively pursuing Lipitor lawsuits for women across the country. If you think that you were injured by your use of Lipitor or use of another prescription drug, you may be entitled to financial compensation. Contact a Lopez McHugh Lipitor attorney today at (877) 737-8525 or fill out a contact form here for a free initial consultation.