FDA Warning: Chantrix May Cause Suicidal Thoughts

Cahntrix (Varenicline) is a Prescription Medication Used to Help Patients Stop Smoking

The United States Federal Drug Administration (FDA) has issued a Public Health Advisory about the increased risk of suicidal thoughts and behaviors by people taking the smoking-cessation drug varenicline (Chantrix). This warning comes after confirming that 39 suicides have occurred in patients taking varenicline (Chantrix). Eighty-seven percent of those suicides have occurred in the United States.

More specifically, the FDA is saying that serious neuropsychiatric symptoms have occurred in patients taking Chantix. These include: changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. According to the data analyzed by the FDA 34 suicides (87% of total reported) have occurred in the United States.

Nicotine is able to attach to a receptor, known as alpha4-beta2 nicotinic receptor, in the smoker brain causing him (or her) a sensation of pleasure. The varenicline drugs works by blocking this brain receptor so the smokers do not feel the need to smoke and it aids in the patients' smoking cessation efforts.

This is the second time that the FDA is warning the public and health care providers about the risks of the drug varenicline. Last year the FDA issue an FDA Early Communication About an Ongoing Safety Review in which was required that Pfizer, the manufactures o the drug, added the possibility of serious neuropsychiatric symptoms in the prescribing label information (pot Marketing experience section).

Today, with this new warning and the analysis that the FDA has done about the drug Chantrix, the FDA is asking Pfizer to add this safety information to the WARNINGS and PRECAUTIONS sections of the Chantix prescribing information. This a stronger form of WARNING that the one set last year.