Chantix Not Linked To Psychiatric Problems, But Findings Not Definitive

Anti-smoking drug Chantix has been tied to psychiatric problems like depression and suicidal thoughts in a new study.

Anti-smoking drug Chantix has not been tied to psychiatric problems like depression and suicidal thoughts in two studies, federal health officials said Monday.

However, FDA officials said the findings from the federally-funded studies on Pfizer's anti-smoking drug are not yet definitive.

Since 2007, the FDA has been investigating reports of mood disorders and erratic behavior among Chantix patients, reports AP.

The agency said in a statement that two studies involving more than 26,000 patients did not show an increased rate of psychiatric hospitalizations among Chantix patients, compared with those using nicotine patches and smoking cessation treatments.

FDA regulators pointed out that the studies only recorded psychiatric problems that resulted in hospitalization, meaning many issues likely went unreported.

Additionally, the studies by the Department of Veterans Affairs and the Department of Defense were not large enough to detect very rare side effects.

Groups like the Federal Aviation Administration have already banned the drug for pilots and air traffic controllers due to side effects that could interfere with their work, AP reports.

The agency said it is continuing to study the problems and recommends patients consult their doctors if they experience side effects while using the drug.

Pfizer is conducting its own large-scale study of Chantix behavioral effects, but the results won't be available until 2017. "Healthcare professionals should advise patients and caregivers that the patient should immediately stop taking Chantix and contact a healthcare professional if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed," the FDA said in an online statement. Since its approval in May 2006, more than 8.9 million people in the U.S. have filled prescriptions for Chantix. Last year Pfizer reported $755 million in sales for the drug, a decline of 14 percent since its peak sales of $883 million in 2007. The news sent shares of Pfizer Inc. rising about 1 percent, or 20 cents, to $19.26 Monday, AP reports. Chantix works by binding to the same spots in the brain that nicotine does when people smoke, blocking nicotine from those spots but causing release of dopamine. The drug's label already carries warnings about possible side effects including hostility, agitation, depression and suicidal thoughts and behavior.  
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