Chantix® Black Box Warning
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Manufacturers of the smoking cessation drug Chantix® are being required by the U.S. Food and Drug Administration (FDA) to add a Black Box Warning to the prescribing information. The mandatory Black Box Warning will highlight the serious side effects associated with the drug.
FDA Chantix® Warning
The FDA announced the new requirement in a Chantix® warning letter July 1, 2009. The FDA Chantix® announcement warned consumers and healthcare providers of the potential side effects and risks associated with Chantix® use, particularly those involving mental heath events, such as:
- Severe depression
- Mood changes
- Irritability, aggravation
- Suicidal thoughts, behavior and/or attempts
The Chantix® Black Box Warning requirement is based on several patient reports that were submitted to the agency. Due to the volume of Chantix® reviews, the FDA is also requiring that the manufacturers of Chantix®, the New York-based Pfizer, Inc., conduct a clinical trial to determine how often neuropsychiatric symptoms occur in users.
Neuropsychiatric Symptoms and Chantix®
Among affected Chantix® users are those who have never experienced a psychiatric disorder. Some of the symptoms to watch out for, if you are using Chantix® to help you quite smoking, include:
- Chronic fatigue
- Severe, unexplained mood swings
- Changes in sleeping patterns
- Changes in eating habits
- Self loathing, lost interest in everyday activities
- Difficulty getting out of bed
- Thoughts of suicide
- Unexplained sadness that you can’t break
If you begin to experience any combination of the listed symptoms and cannot seem to shake the “blues,” it is likely that you are experiencing Chantix®-caused depression. It is important to seek help and stop using the medication immediately.
Compensation May be Available for Chantix® Injuries
If you’ve been harmed by Chantix® use, you will most likely qualify to recover compensation for your losses. Following is a short list of damages often associated with Chantix® side effects:
- Decreased quality of life
- Diminished relationships with family and friends
- Lost income for those who stop going to work
- Lost assets (i.e. home, car, business) for those who default in payments
- Diminished health in cases of eating and sleeping disorders
- Emotional trauma and suffering
Individuals whose loved ones follow through with suicidal thoughts will also be eligible to seek compensation for their losses.
Help for Individuals Harmed by Chantix®
Drug manufacturers such as Pfizer, Inc. have a responsibility to American consumers. When their products harm an individual or family, they should be and can be held accountable for their actions. If you’ve been harmed by Chantix®, don’t let Pfizer just walk away while you struggle to pick up the pieces of your life.
Contact us today to speak with a qualified Chantix® attorney who can help you get the compensation you need to get your life back.
