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Chantix Receives a New Label and a Medical Guide

May 16, 2008

- the U.S. Food and Drug Administration –

Following the FDA Early Communication About an Ongoing Safety Review, issued on November 20, 2008, the U.S. Food and Drug Administration (FDA) updated the label information of Chantix and approved the Medical Guide on this medication. The official news on the updates of Chantix patient information was published on the web-site of FDA on May 16, 2008. Chantix was initially approved in October, 2006 and still remains the only modern medication, specifically designed to help people quit smoking.

The updated label, as well as the Medical Guide, addresses certain safety issues, reported by people after taking Chantix as the anti-smoking therapy. The concerns are based on the reported cases of agitation, depressed mood, changes in behavior, and suicidal thoughts and actions, experienced by patients either right at the beginning of taking Chantix, or during the therapy, or even after stopping Chantix.

In the updated FDA alert, the agency recommends people, considering or already taking Chantix, tell their doctors about the history of any mental disorder prior to starting Chantix. Besides, patients should be especially attentive to any changes in the mood and behavior during the therapy, as well as to vivid, unusual or strange dreams, they may experience while on Chantix. Any of the mentioned cases of should be immediately reported to a healthcare professional.

According to the newly approved Medical Guide, before taking Chantix, patient should tell a doctor about:

- any history of depression or other mental disorder

- kidney problems

- any allergies

- existing or planned pregnancy

- breastfeeding

- use of other medicines (especially, insulin, asthma medicines and blood thinners), vitamins, and herbal supplements.

At the mean time, doctors also received certain recommendations from the FDA concerning Chantix. First of all, they are recommended to carefully monitor all patients taking Chantix for symptoms of a serious mental disorder. According to the available information, such psychiatric illnesses, as schizophrenia, bipolar disorder, and major depressive disorder may worsen during Chantix therapy.

Besides, there is a summarized list of possible side effects of Chantix in the Medical Guide. According to it, the most common adverse reactions, associated with Chantix use, are nausea, sleep problems, including trouble sleeping or vivid, unusual dreams, constipation, gas and vomiting. However, the “Side Effects” section of the Medical Guide also underlines the risk of experiencing new or worsening of the existing mental health problems.

Finally, the Medical Guide gives a clear explanation of how to take Chantix. The document explains that the medication should be started in 7 days before quit date and should be taken for about 12 weeks in total. During this period patient should take different doses of Chantix:

- Day 1-3 – 1 white tablet each day

- Day 4-7 – 2 white tablets each day (one in the morning and one in the evening)

- Day 8 till the end of treatment – 2 blue tablets each day (one in the morning and one in the evening)

Nick

External resources
http://www.fda.gov/cder/drug/infopage/varenicline/default.htm
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Se...
http://www.fda.gov/cder/drug/InfoSheets/HCP/vareniclineHCP.htm