The Chantix label is being updated to warn that it may cause heart problems, including heart attacks, in people with pre-existing cardiovascular disease. The agency is also requiring Pfizer, the maker of Chantix, to conduct an analysis of earlier clinical trials to evaluate the drug’s heart side effects.
The new Chantix heart warning will be included in the “Warnings and Precautions” section of the drug’s label. Chantix, which was approved in 2006 for smoking-cessation, already bears a black box warning regarding its association with psychiatric side effects, including suicidal behavior.
In a Drug Safety Communication issued today, the U.S. Food & Dug Administration (FDA) said that in study of 700 smokers with cardiovascular disease who were treated with Chantix or a placebo, certain cardiovascular adverse events were reported more frequently in Chantix patients. This included seven non-fatal heart attacks in Chantix patients versus 3 in the placebo group.
In its Drug Safety Communication, the FDA advised patients and physicians to weigh the known benefits of Chantix treatment “against its potential risks when deciding to use the drug in smokers with cardiovascular disease.”
This is just the latest problem to plague Chantix in the past several weeks. Last month, the FDA ordered Pfizer to resubmit thousands of adverse event reports over Chantix last year that were not properly reported to the agency. According to a report from the Institute for Safe Medicine Practices (ISMP), the 589 reports of severe side effects – which also included instances of attempted suicide, depression, aggression and hostility -were improperly mixed into reports of minor side effects. The ISMP said the botched reporting may have obscured the true seriousness of Chantix psychiatric side effects.
Shortly after that, regulators in France – where it is sold as Champix – announced that the country’s social security fund would no longer pay for the drug because of its association with psychiatric side effects.
In the U.S., more than 275 Chantix lawsuits that accuse Pfizer of, among other things, playing down the drug’s psychiatric side effects have been consolidated in a multidistrict litigation Alabama federal court.