The US Food & Drug Administration (FDA) has issued a safety alert to warn consumers about an increased risk of Chantix heart attacks, cardiovascular disease and chronic obstructive pulmonary disease (COPD). The FDA is requiring Pfizer, the manufacturer of the smoking cessation medication, to conduct further studies on the side effects of the drug and is changing the drug's label - which already includes a black box warning - to alert Chantix users about recently released clinical trial data.
Unlike other smoking cessation products that use nicotine supplementation, Chantix works to block the pleasurable effects of smoking in the brain, thereby decreasing the desire to smoke and making it easier for the smoker to quit. However, its use has been controversial since it was approved by the FDA in 2006.
In the past five years, an increased risk of suicide; suicidal, psychotic or aggressive behavior; depression and others have been reported as side effects of Chantix. These led the FDA to impose a black box warning on Chantix products in July 2009 to advise users about the increased risks of neuropsychiatric symptoms and other severe behavioral changes associated with taking the drug.
Now the FDA is reporting that Chantix (also known as varenicline) may also cause an increased risk of certain cardiovascular adverse events in patients with cardiovascular disease including angina, COPD and myocardial infarction (heart attack).
According to a press release, the FDA reviewed a randomized, double-blind, placebo-controlled clinical trial of 700 smokers with cardiovascular disease who were treated with Chantix or placebo. It found that, although cardiovascular adverse events were infrequent overall, there were certain events which were reported more frequently in patients treated with Chantix than in patients treated with placebo. Those include increased instances of:
While the FDA says that it will continue to evaluate the cardiovascular safety of Chantix, it is also requiring Pfizer to conduct a large, combined analysis (meta-analysis) of randomized, placebo-controlled trials and is changing the safety information on the Warnings and Precautions section of the drug's label and the patient Medication Guide.
Many of the Chantix lawsuits filed throughout the nation have been consolidated into an MDL (multi-district litigation) in the Northern District of Alabama which will seek to gather information about common Chantix injuries and side effects in order to avoid duplicating efforts of all the parties involved.
If you've been injured by Chantix, contact an experienced Chantix attorney to discuss your situation, find out more about the MDL and determine whether you might be entitled to compensation such as past and future lost wages, past and future medical bills, emotional distress damages and more. A Chantix lawyer can help you to decide what course of action, if any, makes the most sense for you and your family. However, don't delay as all Chantix injury claims must be filed within a specific statute of limitations.