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The U.S. Food and Drug Administration (FDA) announced a Chantix warning, July 1, 2009, alerting consumers of the serious dangers associated with the smoking cessation drug.

Chantix Black Box Warning

Due to the confirmed risks and side effects associated with Chantix, the FDA has required the drug manufactures to include a Black Box Warning on Chantix’s prescribing information. The FDA-required Chantix boxed warning will include the potential risks of serious neuropsychiatric symptoms and mental health events, including:

• Changes in behavior
• Depression
• Hostility, agitation
• Suicidal thoughts & behavior

In the Chantix warning letter, the FDA is encouraging Chantix users to discontinue use of the smoking cessation drug immediately if they begin to experience increased depression or suicidal thoughts. According to the FDA, these side effects can affect anyone, even if they do not have a history of psychiatric disease.

Basis of the Chantix Black Box Warning

The FDA-required black box warning is based on several patient reviews. Many people who were taking Chantix in an effort to quite smoking said they experienced a change in mood, increased depression, and thoughts of suicide and death while taking the drug.

For some, the symptoms subsided once they discontinued use of the drug, but for others, the symptoms continued even after they stopped using the drug.

The FDA also announced that they will be requiring the manufacturers of Chantix, New York-based Pfizer Inc., to conduct a clinical trial to determine how often neuropsychiatric symptoms occur among users.

The FDA has required the same thing from GlaxoSmithKline, makers of Zyban, another smoking cessation drug. Zyban was also included in the FDA warning.

Signs and Symptoms of Depression

If you or a loved one is taking Chantix or another smoking cessation drug, it is important to familiarize yourself with the signs of depression and other neuropsychiatric symptoms. If you or your loved one experience one or more of the following symptoms, you should seek immediate help and discontinue using the medication immediately:

• Changes in mood, increased irritability or agitation
• Feelings of helplessness and hopelessness
• Loss of energy, constant fatigue or sleepiness
• Changes in sleep patterns (you can’t sleep or you sleep too much)
• Concentration problems, normal day-to-day tasks seem difficult
• Loss of control over negative thoughts, no matter how hard you try
• Changes in eating habits (loss of appetite or inability to stop eating)
• Self loathing, thoughts that life is not worth living

Legal Help for Affected Chantix Users

If you begin to experience any of the symptoms listed above, it is important to seek help immediately to prevent these feelings from taking over. After stabilizing your mental health, you should also look into legal help from a qualified Chantix attorney who can help you recover the compensation you need to rebuild your life.

Depending on the severity of your symptoms, Chantix side effects can dramatically change your life. It can take time to regain control of your thoughts and feelings. A Chantix attorney can provide you with the resources and legal support you need to jump start the process.

For more information and help, contact our Chantix attorney today. Fill out the simple form in the right corner of the page and a qualified legal professional will be in touch shortly. We look forward to helping you.

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