Chantix Lawsuit

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FDA Issues Public Health Advisory Linking Popular Anti-Smoking Drug, Chantix to Serious Side Effects, Including the Potential for Severe Changes in Mood and Behavior.

The alert by the U.S. Food and Drug Administration (FDA) was issued to patients, caregivers and health care professionals regarding important changes to Chantix prescribing information. The changes include warnings about serious side effects including:

Changes in behavior
Agitation
Depressed mood
Suicidal thoughts
Anxiety
Nervousness
Tension
Vivid Hallucinatory Dreams
Attempted suicide
Suicide

According to the FDA, while some patients may have experienced these types of symptoms as a result of nicotine withdrawal, some patient’s who experienced these symptoms had not yet discontinued smoking. In most cases the symptoms developed during Chantix treatment however, others experienced these symptoms following withdrawal of the drug therapy.

Since it’s approval by the FDA in 2006, Chantix, also known as Varenicline, has become a leading smoking-cessation drug. The drug is manufactured by Pfizer. Last year, the drug generated $681 million in sales in the U.S. alone ($883 million worldwide). An estimated four million people in the U.S. have taken Chantix since the drug hit the market.

The FDA first informed the public about the possibility of serious side effects associated with Chantix in November 2007. At that time a warning was added to the POST-MARKETING EXPERIENCE section of the prescribing information. However, upon further review the FDA has now requested that Pfizer elevate the prominence of this safety information to the WARNINGS and PRECAUTIONS section of the prescribing information. In addition, the FDA is working with Pfizer to finalize a Medication Guide for patients.

The FDA recommends the following for patients and healthcare professionals

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.
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.

PLEASE DO NOT STOP TAKING ANY PRESCRIPTION DRUG, INCLUDING CHANTRIX, UNTIL YOU HAVE FIRST SPOKEN TO YOUR DOCTOR.

If you believe that you or a loved one has suffered serious injury or death by suicide as a possible result of taking Chantix, you may want to speak with an attorney regarding a potential lawsuit. A lawyer familiar with new developments in the investigation of Chantix may be able to help you make important personal and legal decisions. Please CLICK HERE for a free consultation.

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