Chantix Lawyers Florida

Chantix (varenicline) is a prescription drug used to help people stop smoking. The United States Food & Drug Administration (FDA) approved the drug in May 2006. Manufactured by pharmaceutical giant Pfizer Inc., Chantix is different from other smoking cessation drugs because it is a non-nicotine product that blocks the pleasant effects of nicotine on the brain. While the drug may help some smokers, other smokers that take the prescription experience negative reactions. If you or a loved one experienced harmful side effects after taking Chantix, you may be entitled to monetary compensation.

Chantix Side Effects

Chantix has been linked to psychiatric illness, suicide, and serious injuries caused by loss of consciousness and blackouts. Smokers taking Chantix may experience common side effects:

• Constipation
• Gas
• Headache
• Increased appetite
• Nausea
• Strange dreams
• Taste changes
• Upset stomach
• Vomiting

More severe side effects of the smoking cessation drug may include:

• Behavior changes
• Chest pain
• Fainting
• Fast, slow, or irregular heartbeat
• Glycemic problems, including diabetes
• Hallucinations
• Heart trouble
• Liver failure
• Memory loss
• New or worsening mental or mood problems (i.e. aggression, agitation, anger, anxiety, depression, nervousness, homicidal thinking, thoughts of hurting other people)
• Red, swollen, blistered, or peeling skin
• Seizures
• Severe or persistent nausea
• Stevens Johnson Syndrome (a serious skin disease)
• Suicidal thoughts or actions
• Toxic Epidermal Necrolysis (also known as “Lyell's syndrome,” a skin disorder caused by an allergic reaction or infection)
• Trouble sleeping
• Vision changes
• Vivid, strange, or unusual dreams

Timeline of FDA Investigations and Warnings

The year after Chantix was approved by the FDA, the agency began looking into potential harmful side effects of the drug.

• 2006 (May) – The FDA approves Chantix to help cigarette smokers stop smoking. The FDA also announced that varenicline tartrate, the active ingredient in Chantix, is a new molecular entity that received priority FDA review (allowing Chantix to be approved for sales faster than many other drugs) because of the significant potential benefit to public health.

• 2007 (November) - The FDA began investigating the potential side effects of Chantix, and issued an Early Communication to the public and health care providers about the evaluation.

• 2008 (February) - The FDA released a Public Health Advisory to alert health care providers, caregivers and patients about new safety warnings of Chantix and important changes to the prescribing information for the drug. The warning indicated the possibility of severe changes in mood and behavior in patients taking Chantix, and may cause current psychiatric illness (even if currently under control) to worsen. The drug may also cause old psychiatric illnesses to reoccur.

• 2009 (July) – The FDA notified the public that the use of Chantix was associated with reports of changes in behavior such as hostility, depressed mood, agitation, and suicidal thoughts or actions. The FDA also issued a new requirement for Chantix, ordering that the prescription must carry the agency’s strongest safety warning, called a “Black Box” warning. The warning indicates side effects may include depression and suicidal thoughts.

• 2009 (mid-year) – To date, the FDA had received reports of nearly 100 suicides and 200 attempted suicides linked to patients taking Chantix.

• 2010 (December) A report by Fairwarning.org indicates that Pfizer, Inc. failed to test the drug on the mentally ill or those with a recent history of depression. The report also states that after FDA regulators approved Chantix in a priority review process, the agency did not request a follow-up study on mentally ill patients using the drug even though their own safety reviewer reported that not testing Chantix on these types of smokers might have undermined the clinical trials.   

Chantix Lawsuits

Many smokers who suffered harmful side effects after taking Chantix have already filed lawsuits. The potential to file a Chantix lawsuit is being reviewed and evaluated on behalf of smokers who took the prescription and suffered serious injuries or death, including:

• Diagnosed with new, on-set diabetes
• Diagnosed with Stevens Johnson Syndrom (SJS)
• Diagnosed with Toxic Epidermal Necrolysis (TEN)
• Committed suicide or attempted suicide
• Severe physical injury or death as a result of sudden abnormal behavior, blackouts, seizures, vision disturbances, loss of consciousness or other sudden problems

Contact Burnetti, P.A. at 1-888-BURNETTI

During the first nine months of 2010, sales of Chantix totaled $522 million. In November 2010, Pfizer, the manufacturer of Chantix and the world’s largest pharmaceutical company, estimated that they would make more than $60 billion in sales in 2010.

If you have been seriously injured or lost a loved one because of taking Chantix, you may be entitled to monetary compensation. For more information, contact Burnetti, P.A. at 1-888-BURNETTI.