FDA Adds Cardiovascular Risk Warning to Label of Anti Smoking Drug Chantix

By July 29, 2011 July 18th, 2019 Dangerous Drugs

I have written here before, as a pharmaceutical liability attorney, about the dangerous psychiatric side effects of the drug Chantix (varinicline). Chantix is heavily marketed, especially around the beginning of the year, as a drug that improves smokers’ chances of quitting for good. However, the drug carries a black box warning of serious psychiatric side effects, including hallucinations, depression and suicidal thoughts, and uncharacteristic aggressive behavior. Earlier this month, the Canadian Medical Association Journal published a study with another very serious concern: an increased risk of cardiovascular problems, including heart attack. On July 24, MedPage Today reported that the U.S. Food and Drug Administration has updated the label on Chantix to warn users of an increased risk of heart attack or peripheral arterial disease.
The new study was a meta-analysis of 14 studies of more than 82,00 people, most of whom had no heart problems. Of the 4,900 who took Chantix and not a placebo, nearly twice as many developed serious cardiovascular events. The study’s authors concluded that Chantix might raise the risk of heart attack and stroke by as much as 72 percent, even for people with no previous cardiovascular problems. One author noted that this is especially ironic because quitting smoking is supposed to lower the risk of heart disease. However, the FDA’s new warning is based on another study, which found a slightly increased chance of recurrent heart attack or new arterial disease in smokers who already had well-controlled heart problems.
As a dangerous drug lawyer, I hope potential Chantix patients pay close attention to these studies. The Canadian Medical Association Journal study found that the risks of Chantix outweighs its benefits, because nine out of ten Chantix users generally go back to smoking. This is better than the numbers for unassisted people, but still not a strong benefit. Quitting smoking is genuinely difficult, and for smokers who have tried before and not succeeded, a drug to make it easier might sound like a smart move. But between the cardiovascular risks — which may add to risks already present in a long-term or heavy smoker — and the risk of psychiatric side effects, potential patients face a lot of serious risks for that small benefit.
At Carey, Danis & Lowe, we focus our practice on cases of serious injury or wrongful death caused by medications that were supposed to help. Our defective drug attorneys are based in St. Louis, but we represent people around the United States, in both individual and class-action cases. Most of us trust that a drug wouldn’t be offered for sale if it weren’t safe to use, but unfortunately, that’s not true at all. Pharmaceutical companies don’t always do the necessary due diligence to determine whether their drugs are safe; in some cases, they even cover up information showing how unsafe those drugs are. By bringing a dangerous drug lawsuit, injured people can raise public awareness of the drugs’ safety problems and maybe even prevent another injury. They can also claim the money they need to make ends meet and get needed treatment after a serious injury that was no fault of their own.


If you or someone in your family suffered serious harm from taking a drug you thought you could trust, you don’t have to put up with it. Call Carey, Danis & Lowe today for a free, confidential evaluation of your case. You can reach us toll-free at 1-877-678-3400 or send us an email.
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