FDA Evaluating Chantix Drug Following Reports of Severe Adverse Reactions, Suicidal Behavior
The Food and Drug Administration (FDA) announced it is performing additional safety reviews of Pfizer’s anti-smoking oral medication, Chantix, following reports linking the smoking cessation drug with serious adverse effects. The FDA has received more than 1,000 reports of serious injury associated with Chantix, a figure that exceeds the total amount of reports filed against the top ten best-selling drugs combined.
Unlike other anti-smoking treatments, Chantix works on a neurological level to help smokers break their nicotine addictions. Although it has shown promise as a smoking cessation drug, Chantix, also known as varenicline, is believed to cause loss of consciousness and other adverse mental problems, including suicidal ideation and suicidal behavior.
Consumer advocacy groups are clamoring for a black box warning for Chantix following new reports linking the smoking cessation drug with suicidal ideation and behavior. According to the Institute for Safe Medication Practices (ISMP), the FDA received more than 220 reports of suicidal acts, thoughts or behaviors linked with the use of varenicline. Groups like the ISMP are asking the FDA to take action by issuing a black box warning – the FDA’s strongest action short of a recall request – for Chantix, alerting consumers to the potential link with suicidal behavior and other neuropsychiatric symptoms.
Chantix Blackouts and other Chantix Side Effects
Chantix users have reported a variety of adverse side effects, including blackouts, suicidal thoughts, depression, anxiety, aggression and vivid dreams. The drug has been linked with more than 15 reports of traffic accidents and 52 injuries caused by blackouts. Chantix is strongly discouraged for those operating heavy machinery and has already been banned for airline pilots.
Chantix’s active ingredient, varenicline tartrate, prevents nicotine from reaching neuroreceptors in the brain, preventing the release of dopamine. Without the nicotine-induced dopamine release, smokers no longer experience the same amount of pleasure they once did while smoking. This method differs from traditional anti-smoking treatments, which help ease nicotine addiction through weaning.
If you or someone you know has experienced injury as a result of using Chantix, you may be entitled to compensation. Defective drugs fall under strict product liability laws, which can award both compensatory and punitive damages to victims. Failing to supply sufficient warning labels and information about the risks can make pharmaceutical companies liable for victims’ injuries.
The defective drug lawyers at Aylstock, Witkin, Kreis and Overholtz comprise an experienced team that has won numerous high profile personal injury and product liability cases. With their guidance and expertise, the Aylstock, Witkin, Kreis and Overholtz law firm can review your claim and help create a strong case against negligent companies. Contact AWKO law today at (844) 794-7402 and begin your journey toward fair compensation.