If you took the smoking cessation drug Zyban (bupropion) while you were pregnant and your child was born with a birth defect, this popular medication could be to blame. In recent studies, Zyban has been linked to serious heart, lung and cranial birth defects. If you took Zyban during pregnancy and your child was born with any of the congenital abnormalities mentioned in this article, you may be eligible to file a Zyban birth defects lawsuit.
Zyban Birth Defects Lawsuit Review:If you or somebody you know has a child that has been diagnosed with a birth defect related to Zyban, you should contact our lawyers immediately. Consultations are always free. Please use our confidential email contact form or call toll free 24 hrs/day by dialing (866) 588-0600.
Which birth defects have been linked to Zyban?
Zyban is a drug that may interfere with the development of a fetus which may result in serious congenital abnormalities. The following is a list of birth defects that are currently being evaluated for potential Zyban lawsuits:
- Atrial Septal Defects
- Ventricular Septal Defects
- Ebstein’s Anomaly
- Mitral Valve Prolapse
- Transposition of the Great Arteries
- Tetralogy of Fallot
- Hypoplastic Left Heart Syndrome (HLHS)
- Hypoplastic Right Heart Syndrome (HRHS)
- Tricuspid Valve Stenosis
- Tricuspid Atresia
- Aortic Stenosis
- Patent Ductus Arteriosus (PDA)
- Coarctation of the Aorta
- Truncus Arteriosus
- Heart Murmur
- Pulmonary Stenosis
- Pulmonary Atresia
- Gastroschisis – abdominal wall defect
- Esophageal Stenosis
- Esophageal Atresia
- Anal Atresia
- Spina Bifida
- Neural Tube Defects
- Hand Malformations
- Cleft Lip
- Cleft Palate
- Fetal Death
- Growth Retardation
- Persistent Pulmonary Hypertension of the Newborn (PPHN)
- Mental Retardation
- Down Syndrome
- Dandy Walker Syndrome
- Undescended Testicles
- Cloacal Exstrophy
- Heart Malformations
Zyban Birth Defects Study
In 2010, a case-control study published in the American Journal of Obstetrics and Gynecology found that expecting mothers who take Zyban during the first trimester of pregnancy – a time when many women may still be unaware that they are pregnant – may run a greater risk of giving birth to a baby with a congenital birth defect. The research identified a positive correlation between early pregnancy Zyban use and left outflow tract heart birth defects. The study’s authors concluded by cautioning women taking Zyban who are pregnant or planning to become pregnant to speak with their doctors about the potential side effects as well as alternative courses of treatment.
Manufactured and marketed by GlaxoSmithKline (GSK), Zyban (bupropion hydrochloride) is an FDA-approved non-nicotine smoking cessation treatment designed for use in patients who want to quit smoking. First approved for sale on the U.S. market in 1985, bupropion is also commonly prescribed for depression and seasonal affective disorder (SAD) under the brand-name Wellbutrin. Bupropion is also sometimes prescribed in an ‘off-label‘ capacity (for which it was neither tested nor approved by the FDA) for the following conditions:
- weight loss
- bipolar depression
- Crohn’s disease
- restless leg syndrome (RLS)
- pathological gambling
- SSRI/SNRI-induced sexual dysfunction
How Does Zyban Work?
Zyban is designed to work by increasing neurotransmitter levels in the brain, thereby curbing an individual’s desire to smoke. The drug controls the rate at which the brain’s synapses reabsorb released chemicals such that they remain in the synaptic gap for an extended period of time, theoretically improving the patient’s thought patterns. It is important to note that Zyban is part of the aminoketone class of medications, and is chemically different from other antidepressants on the market. Unlike drugs from the selective serotonin reuptake inhibitor (SSRI) class that target the neurotransmitter serotonin, Zyban acts on the brain chemicals dopamine and norepinephrine. Because of its unique makeup, Zyban may also have different side effects in users, and it may work for patients who have had no success with other similar drugs.
When taken to treat smoking cessation, Zyban is normally prescribed to help reduce nicotine cravings and the severity of side effects associated with nicotine withdrawal. Different from other anti-smoking treatments, Zyban does not add nicotine into the body. After beginning a regimen, patients are allowed to smoke for a period of time, gradually reaching a quit date, then continue to take the drug for a prescribed period of time after quitting.
Zyban is currently classified by the FDA in Pregnancy Category C, which means that animal reproductive studies have shown an adverse effect on the fetus, and that no adequate long-term controlled studies in humans have been conducted to date.
Zyban Mental Health Side Effects
In addition to the risk of the birth defects listed above, Zyban has also been linked to serious mental health events in users including:
- radical changes in behavior
- depressed mood
- suicidal thoughts
These risks are so severe that in July 2009, the FDA announced that it was requiring GSK to put a so-called ‘black box’ warning – the strictest such warning allowed by law – on the prescribing information section of Chantix labels. The press release stated that healthcare professionals who prescribe Chantix should monitor patients for any unusual changes in mood or behavior occurring after initiating a regimen of Chantix. Patients are advised to contact their healthcare providers immediately if they experience such changes.
“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” says Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”
Is there a time limit in filing a Zyban birth defects lawsuit?
Although we encourage all our potential clients to take great care in selecting their Zyban birth defects lawyer, it is important that you understand that time is of the essence. The applicable statute of limitations in your state may time bar your claim. Furthermore, we are unable to provide you with legal advice without first evaluating your potential case. Accordingly, please take the time now to contact us by using the confidential email contact form below or by calling us toll free 24 hrs/day by dialing (866) 588-0600.
We hope we will be able to assist you with your potential Zyban birth defects lawsuit and look forward to speaking with you.
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