JULY 1, 2009 – CNBC reported this morning the FDA will address the safety of Chantix (also known as varenicline), Pfizer’s stop-smoking drug. A telephone briefing was held Wednesday morning about Chantix and its serious neuropsychiatric side effects. Over eleven million prescriptions have been written for Chantix, a nicotinic receptor partial agonist, which is used for treatment of nicotine addiction. The FDA is looking into serious reports of serious neuropsychiatric side effects, but has not ordered the drug to be pulled off the market. Pfizer has experienced declining sales of Chantix this year, reportedly down more 40%. A Pfizer spokesman said the safety profile of the drug “remains favorable.”
Concerns of heart and vision effects as well as psychological behavior changes have been reported. The drug works by binding to the brain’s nicotine receptors, which reduce cravings, but also may cause various psychological effects, including aggressive behavior and suicidal thoughts. The Federal Aviation Administration (FAA) has banned commercial pilots from using Chantix.
The FDA issued a news release on July 1, 2009, announcing that it is requiring Pfizer and GlaxoSmithKline (manufacturer of Zyban) to put a Boxed Warning on the prescribing information for Chantix and Zyban about serious mental health events associated with the drugs. Read the FDA’s news release here.
Pfizer issued a news release on July 1, 2009, stating they were updating their labeling to communicate safety information to physicians and patients. The boxed warning states “that the safety and efficacy of CHANTIX in patients with serious psychiatric illness have not been established.” According to Pfizer, “The updated label highlights safety information about reports of serious neuropsychiatric events in a boxed warning, [and] updates the warning about reports of neuropsychiatric symptoms and suicidality. Read the press release in its entirety here.
In a recent criminal case out of Pennsylvania, a man blamed the drug for inducing a rage that caused him to smash his Bobcat lawn tractor into one of the supports of his home while his wife was inside. Numerous other lawsuits have been filed against Pfizer by families of people who have committed suicide while taking Chantix and people who have been seriously injured while attempting to commit suicide.
In June 2008, ABC News reported both the FDA and Pfizer were told of adverse effects from longer-term usage of Chantix in 2007. A report from the Institute for Safe Medicine Practices referenced nearly 1,000 reports of adverse events associated with Chantix.
