FDA Issues Chantix Public Heatlh Advisory

Author: Alan Haburchak

On February 1st, 2008, the Food and Drug Administration (FDA) issued a public health advisory, giving new information about the risks of taking the prescription medicine Chantix, or Varencline Tartrate.

It stated that the drug's manufacturer, Pfizer, had reviewed and updated the prescription information for the drug, adding warnings alerting people to risks of intense mood and behavior changes. Further, it reiterated the necessity of communication between patients and their doctors regarding previous psychiatric illness, stating again that Varencline could not only be responsible for new conditions, but also exacerbate existing conditions or rekindle previous conditions. Additionally, it issued several warnings:

* Patients should tell their doctor about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of a current psychiatric illness even if it is currently under control and may cause an old psychiatric illness to reoccur.

* Healthcare professionals, patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy.

* Patients taking Chantix should immediately report changes in mood and behavior to their doctor.

* Patients taking Chantix may experience vivid, unusual, or strange dreams.

* Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.
While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert patients that they are possible.

These are not the first Chantix warnings announced by the FDA. In November 2007, the FDA began investigating reports of depression, agitation and suicidal behavior among patients taking the medicine, after they had received reports of 37 suicides and more than 400 of suicidal behaviors in connection with the drug. A link between Chantix and serious psychiatric complications became progressively probable. Additionally, the FDA determined that there might be other adverse side effects of Chantix such as the further worsening of preexisting psychiatric illness or causing a recurrence of past psychiatric issues. Two weeks after this initial FDA report, Pfizer added stronger Chantix warning labels to the drug, stating publicly that while a direct link between Chantix and the reported psychiatric problems did not exist, the possibility of Chantix-induced psychotic episodes could not be ruled out.

Most recently, the FDA has been evaluating reports that in addition to erratic behavior in patients taking Chantix, suicidal thoughts, depression, and changes in the emotional state are present in many cases. These Chantix psychiatric adverse events can set in within days or weeks of beginning the Chantix treatment. In fact, many patients taking the medicine have posted their feelings online, seeking support after a highly-publicized shooting that was linked by the media to the drug. Most of these people describe intense nightmares, paralyzing depression, consuming apathy, anxiety, or thoughts of suicide. Many of these cases were linked to alcohol consumption and the interaction that it has with the drug. While there is not a definitive Chantix-suicide connection in a controlled testing, there is ever-mounting evidence raising concern.

While there is not as of yet a current Chantix class-action lawsuit against the manufacturer, Pfizer, the public outcry for reform, reparation and compensation for the damages done grows larger every day. No doubt that with the release of the FDA's most recent review of the drug and it's potentially fatal side effects that there will soon be litigation against the company. To be sure, even Pfizer admits to a certain risk of taking the drug, although none so serious as the actuality of many of the cases. It would be wise for anyone who has firsthand experience with suicidal thoughts or severe depression from taking Chantix, or who has been affected by someone who is or was taking Chantix, to contact a health care provider as soon as possible.

Once the health of anyone taking Chantix has been assured, it may be in the best interest of any Chantix patient or their families to consider contacting an expert Chantix law firm in order to receive experienced counsel on possible Chantix damages that may be sought for those effected by the possible danger of Chantix suicide.


Article Source: http://www.articlesbase.com/medicine-articles/fda-issues-chantix-public-heatlh-advisory-343810.html