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Chantix – Safety Concerns Arise

November 20, 2007

- the U.S. Food and Drug Administration –

During a year since its approval by the U.S. Food and Drug Administration (FDA) in October 2006, Chantix or varenicline tartrate received mostly positive feedbacks from the patients, who managed to quit smoking with its help, and from the doctors, who, finally, received a medication, specifically designed to treat nicotine addiction. However, recently the FDA published ongoing safety review on Chantix, based on the data which became available during the marketing period of this drug.

As it is known and clearly stated on Chantix official web-site, the most common side effects associated with varenicline use are nausea, sleep disturbances, constipation, gas and vomiting. Though Pfizer, Inc, the manufacturer of Chantix, mentions that these are not all the side effects of Chantix, it does not name the other adverse reactions.

At the meantime, in response to the FDA request for post-marketing information from the manufacturer, Pfizer has recently submitted reports describing suicidal thoughts, aggressive and erratic behavior, as well as drowsiness in patients, treated with Chantix.

The agency found out that the use of Chantix was associated with the suicidal ideation in a number of cases; besides, it was also reported about certain suicidal behavior in the patients undergoing Chantix therapy. The post-marketing reports also revealed new-onset of depression in patients, changes in their emotional and usual behavioral patterns, which developed within days to weeks after starting the Chantix treatment course.

Of course, depression and certain mood changes can be treated as the withdrawal symptoms associated with smoking cessation, as it is known that during quitting process patients usually experience the exacerbation of underlying mental illnesses, including depression and anxiety. However, the reports say that not all the patients, suffering from depressed mood in association with Chantix therapy, had any signs of depression before initiating the treatment.

Aggressive and erratic behavior is another safety issue under the evaluation by the FDA experts. The agency is aware of one case of such erratic behavior leading to the death of a patient, who tried to quit smoking with the help of Chantix. However, this case is very complicated because of additional factors, such as alcohol abuse, which could also cause erratic behavior.

Pfizer Inc. has also submitted data showing the association between drowsiness and Chantix therapy in some patients. That is why it is recommended to drive and operate machinery with special caution.

However, it should be kept in mind that all the safety issues described above are not yet officially evaluated and there is no official decision from the FDA concerning those issues. The data above is only a reflection of what the FDA is currently reviewing referring Chantix.

Till new data arises or the FDA issues some official decision in this regard, the agency recommends all the doctors and health-care providers prescribing Chantix to pay attention to the possible mood and behavior changes in patients. Besides, patients are also encouraged to talk to their doctors in case any psychological changes arise while on Chantix.

Nick

External resources
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01749.html
http://www.fda.gov/cder/drug/early_comm/varenicline.htm
http://www.chantix.com/content/side_effects_safety.jsp?setShowOn=../content/A...