Despite recent efforts by Pfizer to reduce warning requirements for its smoking cessation drug Chantix, the FDA announced this week that the existing warnings about the potential neurological and psychological side effects of Chantix would remain, and that new warnings would also be added to the Chantix drug label. In the drug safety communication, issued on March 9, the FDA warns users about the potential risk of seizures from Chantix, and the risk of other side effects that may result from combining Chantix with alcohol. If you used Chantix in the past, and you have since suffered a major side effect like seizures, contact a knowledgeable Chantix lawyer today to discuss your legal options.
Chantix (varenicline) is a prescription drug manufactured by Pfizer and approved by the FDA in 2006, as a treatment to help people quit smoking. When it was introduced to the market in the United States, Chantix was seen by many as a safe and effective way for people to stop smoking cigarettes. However, serious concerns have been raised recently about the potential risk of side effects from Chantix, and just three years after it was approved, the FDA required Pfizer to add a “black box” warning to the Chantix label, warning users about the alleged link between Chantix and the emergence of unusual behavior, including suicidal or homicidal thoughts.
Although Chantix was originally seen as a potential blockbuster smoking cessation drug, Pfizer and its medication have been plagued by concerns about the risk of psychological and neurological side effects of Chantix, and now an additional risk of seizures and alcohol intolerance. These new FDA warnings come just one year after Pfizer attempted to get the Chantix “black box” warning removed, arguing that new studies raise doubts about whether the drug is actually associated with any neurological or psychological side effects. FDA reviewers found that Pfizer’s data regarding this issue was “insufficient in quality” and determined that the “black box” warning should stay.
In addition, the agency has decided that new warnings about the risk of seizures and alcohol interaction should be added to the Chantix label, after an analysis of the FDA’s Adverse Event Reporting System database found 48 adverse events link to aggressive behavior and decreased alcohol tolerance in Chantix users. The FDA also found 64 cases of patients suffering seizures after taking Chantix, 37 of which involved patients with no prior history of seizures. “Until patients know how Chantix affects their ability to tolerate alcohol, they should decrease the amount of alcohol they drink,” the new FDA warning states. “Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately.”
When the FDA first added the “black box” warning to the Chantix label, Pfizer was hit with close to 3,000 product liability lawsuits filed on behalf of patients who alleged that the drug maker failed to provide adequate warnings about the potential risk of side effects from Chantix. If you believe you have been adversely affected by side effects of Chantix, our consumer advocates at the Consumer Justice Foundation can help. We are committed to protecting the rights of consumers harmed by dangerous medications, and can help put you in touch with a qualified attorney who has experience handling Chantix side effect claims.