FDA Releases New Safety Warning About Heart Attacks and Strokes in Chantix Users

By December 27, 2012 July 18th, 2019 Dangerous Drugs

I’ve written here many times, as a dangerous drug lawyer, about ongoing lawsuits alleging that the anti-smoking drug Chantix (varenicline) causes suicidal behavior and aggression in otherwise well-balanced people. Now, the U.S. Food and Drug Administration has released a new safety communication with research suggesting that Chantix may cause heart problems. According to Bloomberg News, research has found more heart attacks and strokes in Chantix users than in those who took a placebo, and the higher rate is unlikely to be caused by mere chance. The label already carries a warning that Chantix may be tied to heart problems in people who already have cardiovascular disease. The new announcement grew out of a study following up on that finding.
Chantix, made by drug manufacturer Pfizer, helps smokers quit smoking by blocking the effects of nicotene. Smoking is itself a risk factor for cardiovascular problems, which is one reason why the FDA released its previous cardiovascular safety warning in June of 2011. That communication said a controlled study comparing Chantix takers to placebo takers, both with cardiovascular disease, had found an increased risk of serious cardiovascular problems in the Chantix takers. This led the FDA to add a warning to the drug’s packaging in 2011. The agency also required a followup study analyzing clinical trials of Chantix. That study found a similar increased risk in the general population–not just in Chantix users who have cardiovascular disease. The FDA emphasized that the risk is not statistically significant, which means it’s not clear whether the results are chance, but it said the results are more likely due to a safety problem with Chantix.
Chantix is very effective at helping some smokers quit, but it has a spotty safety record even without the potential cardiovascular problem. As early as 2007, the FDA was announcing reports of depression and suicide in Chantix users. The patients making the reports had not necessarily stopped smoking, so the symptoms could not all be attributed to nicotene withdrawal. As a result, the FDA required a black box warning, the strongest it requires, on the label several years ago. The first of many lawsuits alleging Chantix caused suicide or suicide attempts was settled in October, on the eve of trial, for a confidential amount. More are pending in Alabama federal court, where they have been consolidated. The next such lawsuit is scheduled for January 22, and it’s possible that the court will require several Pfizer executives to testify.
The announcement that there may also be a cardiovascular risk from Chantix is important news for pharmaceutical liability attorneys like me. The suicide and suicidal thoughts risk is certainly very serious, but it can be hard to prove because mental health is harder to document and demonstrate than physical health. If the FDA’s research is borne out, there may be another set of lawsuits coming with a better-documented risk of life-threatening heart attacks and strokes. As the FDA notes, this is especially troublesome because smoking already increases the risk of experiencing one of these problems. Adding another risk is therefore very bad news for patients who are trying to cut their risks down by stopping smoking. As a defective drug lawyer, I will watch with interest for future FDA updates.


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Similar blog posts:
Pfizer Settles First Bellwether Case Alleging Chantix Caused Suicide and Depression
FDA Adds Cardiovascular Risk Warning to Label of Anti Smoking Drug Chantix
Anti-Smoking Drugs Chantix and Zyban Get Black Box Warning About Risk of Suicide and Mental Illness