ePillz.com - FDA Requests New Safety Warnings on Chantix

FDA Requests New Safety Warnings on Chantix

February 1, 2008

-Food and Drug Administration –

On February 1, 2008, the U.S. Food and Drug Administration (FDA) published a Public Health Advisory to warn all the doctors, healthcare providers and patients, receiving Chantix as the treatment against smoking, about the new safety issues, which became known after the medication had been approved by the FDA.

Less than three months ago, the FDA issued an Early Communication, informing the public and health care providers that the agency was working to evaluate the post-marketing reports on the side effects, associated with Chantix use. Mostly, the concerns were changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior. The article on this Early Communication from the FDA can be accessed at the following address http://www.epillz.com/info/chantix-safety-concerns-arise.html.

Though the FDA is still in the process of reviewing adverse reactions reports on Chantix, already available findings let the agency state in its press-release that “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms”.

As the result, the FDA requests from Pfizer, Inc, the manufacturer of Chantix, to change the warning and precautions section on Chantix labels to draw more attention of patients and doctors to the potential side effects of psychiatric origin. So, it looks like in the nearest future Chantix will get the new label with greater emphasize on the potential mental side effects.

In the meantime, the FDA included in the Public Health Advisory a few recommendations for the patients, caregivers, and health care professionals:

Tip#1. Patients should tell their health care provider about any history of psychiatric illness prior to starting Chantix.

It is said that Chantix may cause worsening of the current mental disorder or the medication may cause the recurrence of some old psychiatric illness, that have already been treated and, perhaps, even cured in the past. Besides, it is interesting to note here that the patients with the history of mental disorders were not included in the clinical studies, conducted for getting the FDA approval of Chantix.

Tip #2. Health care professionals, patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix.

The FDA experts recommend people to be attentive to such symptoms as anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide, which may appear not only in people currently on Chantix, but also in those, who have just stopped the therapy.

Tip #3. Patients should immediately report changes in mood and behavior to their doctor.

Communication with doctor, who prescribed the medication, is the essential part of any treatment. In case with Chantix, it is important for the doctor to know all the symptoms his patient experiences in order to evaluate all the risks and benefits of the therapy.

Tip #4. Vivid, unusual, or strange dreams may occur while taking Chantix.

It is recommended to let the doctor know about any changes in the sleep patterns or unusual dreams, experienced during the Chantix treatment period.

Tip #5. Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

Since Chantix works in brains, many people say that they experience a kind of “fog” in their heads during taking Chantix. So, it may be a good idea to avoid driving a car or working with some machinery while taking Chantix.

Nick

External resources
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01788.html
http://www.medicalnewstoday.com/articles/96240.php
http://www.epillz.com/info/chantix-safety-concerns-arise.html