FDA Warning: Chantrix May Cause Suicidal Thoughts

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.

The FDA is not asking doctors to recommend their patients to stop using the drug but because Chantix may worsen current psychiatric illness they are asking patients to inform their doctors about any history of psychiatric illness previous to starting the drug. Also, the FDA is asking patients, patients' families, and doctors to stay alert about any of the following events: anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide.

Some medical experts believe that drugs such as verenicline are not needed for smoking cessation. They argue that the safety concerns about many of these drugs are not balanced by the benefits seen. They believe that smoking, although addictive, can be stopped when the patient decides to do it. However, appropriate psychological and medical advice will certainly support the patients' efforts to stop smoking.

Source:

Varenicline (marketed as Chantix) Information. FDA Public Health Advisory URL: http://www.fda.gov/cder/drug/infopage/varenicline/default.htm

FDA Early Communication About an Ongoing Safety Review URL: http://www.fda.gov/cder/drug/early_comm/varenicline.htm