In the past five years, Chantix side effect studies have indicated that patients with heart disease taking Chantix have an increased risk of suffering serious adverse side effects. According to new research, these life-threatening side effects are equally prevalent in patients without heart disease taking Chantix. Among these potential Chantix side effects are:
When Pfizer presented Chantix to the FDA for approval in 2006, the drug received a “priority review,” shortening the typical ten-month review period to only six months. This FDA action was taken because of the drug’s demonstrated effectiveness in clinical trials and perceived lack of safety issues. Perhaps if the FDA had used the full ten months to review the safety and effectiveness of Chantix, the agency would have more quickly discovered the potential dangers of Chantix side effects.
In June 2011, the FDA issued a safety announcement warning patients and healthcare professionals that Chantix may be associated with an increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This warning came on the heels of a clinical trial in which serious side effects like heart attack were reported more frequently in patients who used Chantix compared to patients who took a placebo. According to the FDA, smoking is a major risk factor for cardiovascular disease, and smoking cessation drugs like Chantix are of particular importance to these patients. The FDA advises patients and healthcare professionals to consider the potential risks and possible benefits of Chantix before making the decision to use the drug in patients with cardiovascular disease.
Even more alarming, a new study conducted by researchers at Johns Hopkins University and Wake Forest Baptist Medical Center indicates that the smoking cessation drug Chantix may also increase the risk of cardiovascular events, including heart attack and stroke, in patients without cardiovascular disease. According to the report, Chantix use was associated with a significantly increased risk of serious adverse cardiovascular events greater than 72% in patients with and without cardiovascular disease. This study was published in the Canadian Medical Association Journal on July 4, 2011. In light of this new Chantix side effect information, experts have asked that the FDA institute a Chantix recall due to the fact that the potential risks of the drug seem to outweigh the possible benefits. FDA representatives have reported that the agency is investigating this new Chantix side effect data in order to assess the need for additional warnings on the Chantix label.
The potentially harmful nature of Chantix has been apparent since the drug was approved five years ago. In 2007, only a year after Chantix garnered FDA approval, the drug accounted for more occurrences of serious injury than any other drug, according to the FDA’s adverse events reports. Among these Chantix side effects were seizures, irregular heartbeat and blackouts, as well as serious psychiatric side effects like suicide and aggression. In 2008, the Institute for Safe Medication Practices (ISMP) published its findings regarding Chantix side effects, which led the FDA to order pilots with the Federal Aviation Administration to stop taking Chantix. Shortly after, the Federal Motor Carrier Safety Administration, which oversees the trucking and bus industry, issued a similar Chantix ban for its commercial drivers. Concerned about these serious Chantix side effects, the Department of Defense also prohibited certain weapons and aircraft personnel from using Chantix.
Despite mounting evidence about Chantix side effects, the FDA claims it was unaware of the heart risks associated with Chantix until Pfizer conducted a study in 2010. The results of this study caught the attention of the FDA, leading the agency to issue the recent Chantix safety announcement. The FDA does acknowledge, however, that there were hints of heart issues present in the original data that Pfizer submitted to garner approval for Chantix in 2006. If you or a loved one has suffered from a serious side effect which you believe to be associated with the smoking cessation drug Chantix, contact a Chantix attorney to discuss your legal options. You may be entitled to financial compensation for your injuries and medical expenses, which you can collect by filing a Chantix lawsuit against Pfizer. Drug companies like Pfizer are responsible for the safety of their medications and should be held accountable for any adverse side effects sustained by consumers. With the help of a qualified Chantix lawyer, victims of Chantix side effects can protect their rights and collect the compensation they deserve.