“What Is the Problem with Wellbutrin?” Organized by the lawyers at Anapol Schwartz. © 2010 All Rights Reserved. Contact Lawyers: Jim Ronca, Esquire Call: 866.735.2792 Email: [email protected] Read more information about Wellbutrin Lawsuits at www.anapolschwartz.com Wellbutrin, a popular antidepressant, has been linked to heart-related birth defects for women who took the drug one month prior to getting pregnant and during the first trimester of pregnancy. Contents • About Wellbutrin 2 • What Are the Infant Birth Defects Associated with the Bupropion Pregnancy Registry? • What Is the Risk in Numbers? 3 • What Is a SSRI Antidepressant? 3 • Does Wellbutrin Have Side Effects? This document is dedicated to providing public information regarding unsafe drugs and other legal information. None of the information on this site is intended to be formal legal advice, nor the formation of a lawyer or attorney client relationship. Please contact a Wellbutrin Lawyer, for information regarding your particular case. This document is not intended to solicit clients outside the States of New Jersey and Pennsylvania. 2 4 • What Is Zyban? Does Zyban have side effects? 4 • Should I File a Wellbutrin Heart Defect Lawsuit? 4 • Resources 5 Medical Disclaimer: This site is not designed to and does not provide medical advice, professional diagnosis, opinion, treatment or services or otherwise engage in the practice of medicine, to you or to any other individual. Please use this information to help in your conversation with your physician. This is general information and always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard or delay seeking professional medical advice or treatment because of content found on the Website (or newsletter). About Wellbutrin What drugs have the heart birth defect risk? Wellbutrin®, Wellbutrin SR®, Wellbutrin XL®, and Zyban® to stop smoking What is Bupropion? This is the generic term for Wellbutrin and Zyban. Who makes Wellbutrin? GlaxoSmithKline What Are the Infant Birth Defects Associated with the Bupropion Pregnancy Registry? From March 1997 through March 31, 2008 the GlaxoSmithKline Bupropion Pregnancy Registry report listed the following birth defects for first trimester or earlier exposure: • Live infant with bilateral clubfeet • Live infant with abnormal aortic valve thickening with secondary mild aortic insufficiency • Live infant with Klinefelter’s Syndrome with no physical abnormalities diagnosed by amniocentesis • Live infant with ventricular septal defect • Live infant with trivial valvular pulmonic stenosis and tiny atrial septal defect • Induced abortion with evidence of Down syndrome on a prenatal test • Live infant with congenital heart defect (coarctation) and ventricular septal • Live infant born premature with a thickened heart muscle • Live infant with pulmonary stenosis • Live infant with coarctation of the aorta “WHAT IS THE PROBLEM WITH WELLBUTRIN?” Copyright © 2004–2010 All rights reserved. Anapol Schwartz. Read more information about Wellbutrin Lawsuits at www.anapolschwartz.com • Fetal death with congenital pulmonary lymphangiectasis in one lung, secundum atrial septal defect, cleft palate, protuberant maxilla, low set ears, flattened pinnae and kyphosis • Live infant with Trisomy 21 • Live infant with Trisomy 18 • Induced abortion with Down syndrome • Spontaneous abortion with Trisomy 14 • Induced abortion with ultrasound diagnosis of a left diaphragmatic hernia with intestine in the thorax • Live infant with bilateral kidney dilation from reflux diagnosed prenatally and double ureters • Induced abortion with Jeune’s syndrome (thoracic dysplasia with short limbs) diagnosed prenatally • Live infant with hypospadias and cleft right ear lobe • Induced abortion with anencephaly • Live infant with bilateral club feet (family history). • Live infant with mixed superficial and deep hemangioma, left eyelid, requiring laser photocoagulation. • Live infant with atrial septal defect with patent ductus arteriosis and patent foramen ovale • Live infant with duplicate left renal pelvis • Live infant with left hand with misshapen thumb, index, middle and ring fingers Has the U.S. Food & Drug Administration (FDA) issued any safety alerts or black box warnings for Wellbutrin heart defects? Not as of this writing (Nov. 2010) Has GlaxoSmithKline issued any safety missives or contacted doctors or patients about the correlation between heart birth defects and Wellbutrin? Not as of this writing (Nov. 2010). Results from the Bupropion Pregnancy Registry have not been published for wider distribution by GlaxoSmithKline. 2 Have there been any studies published about the correlation between Wellbutrin and birth heart defects? What Is a SSRI Antidepressant? Yes, the American Journal of Obstetrics & Gynecology published a recent study alerting doctors about the possible risks between taking Wellbutrin during the first trimester and congenital heart birth defects. Mothers who used Wellbutrin during early pregnancy had more than double the risk of heart defects compared to infants whose mothers had not used Wellbutrin. Selective serotonin reuptake inhibitors are a class of compounds typically used as antidepressants in the treatment of depression, anxiety disorders, and some personality disorders. What Is the Risk in Numbers? Two out of every 1,000 infants may suffer congenital heart defects. For all congenital malformations, the prevalence associated with 1,213 bupropion first trimester exposures was 23.1 per 1,000 infants. What is a congenital heart defect or CHD? Is Wellbutrin the only antidepressant that is unsafe to take during the first trimester? No, many antidepressants are unsafe during pregnancy such as Paxil, Prozac, Zoloft, and Celexa. Discontinuing some antidepressants may cause thoughts of suicide especially in people who are younger than 25 years of age. Some doctors are rethinking prescribing antidepressants during pregnancy and suggesting counseling and psychotherapy recommendations instead. Doctors and their patients have to weigh the risks and benefits for pregnant women. A congenital heart defect is a problem with the structure of the heart which is present at birth. Congenital heart defects are the most common type of major birth defect. What are some of the heart defects affecting Wellbutrin babies? • Coarctation of the aorta (CoA) • Pulmonary stenosis (PS) • Thickened heart muscle is right ventricular hypertrophy (RVH • Atrial septal defect (ASD) • Ventrical septal defect (VSD) • Heart ventricle outflow track defects How does pregnancy affect depression? Pregnancy hormones were once thought to protect women from depression, but with millions of pregnant women now taking antidepressants that is a myth. Being pregnant doesn’t make depression worse, but triggers emotions which make it more difficult to cope with depression. “WHAT IS THE PROBLEM WITH WELLBUTRIN?” Copyright © 2004–2010 All rights reserved. Anapol Schwartz. Read more information about Wellbutrin Lawsuits at www.anapolschwartz.com 3 Does Wellbutrin Have Side Effects? Should I File a Wellbutrin Heart Defect Lawsuit? Yes. Seizure is the most controversial side effect. The risks of seizures caused Wellbutrin’s initial withdrawal from the market. The risk of seizure is dose-dependent. Other side effects are hypertension, dry mouth, nausea, headache, insomnia, tremor, excessive sweating, constipation, rash, and tinnitus. It’s quite possible that you should and here’s why: Your baby may require expensive procedures that health insurance will most likely not cover or not cover in their entirety. There will be ongoing therapy, costly care giving, and numerous prescription drugs. If employed or self employed, you may need to take time off work. You, your family, and your baby’s pain and suffering will be all consuming. A lawsuit can help pay for medical bills and expenses. What Is Zyban? Zyban is a prescription drug that was originally designed to be an antidepressant but has been found to be effective in helping individuals stop smoking by reducing withdrawal effects from nicotine. Does Zyban have side effects? Yes. The most common side effects are dry mouth and trouble sleeping. Zyban tends to reduce the amount of weight gained when quitting smoking which is perceived as a good side effect. Some people experience an increased interest in sex which can be good or bad depending on your situation. People taking Zyban are more likely to have seizures than people not taking Zyban. More Zyban side effects may include mood changes, anxiety, panic attacks, trouble sleeping, feeling impulsive, agitated, hostile, hyperactive, and more depressed, or have thoughts about hurting yourself. When is the best time to file a Wellbutrin birth defect lawsuit? The sooner the better—it takes time to compile information and hospital records. Every state has what is called statute of limitations and places limits on how long the injured party can wait to file a lawsuit. The last thing you want to do is lose that opportunity to file. That would be considered reckless behavior. What is the statute of limitations to file a lawsuit? In Pennsylvania, New Jersey, and West Virginia, a personal injury lawsuit must be filed within two years of the date when the injury occurred. How much does it cost to file a lawsuit? Clients pay no out-of-pocket expense and only pay if and when their settlement is received. A settlement affords you compensation for mounting medical bills, caregivers, loss of income (if still working), and pain and suffering. Who is Anapol Schwartz? Anapol Schwartz upholds traditions of excellence in medical malpractice, pharmaceutical, toxic tort, class actions, products liability, and automobile accident litigation. Law offices are located in Pennsylvania, New Jersey, West Virginia, Arizona, and of Counsel in Ohio. “WHAT IS THE PROBLEM WITH WELLBUTRIN?” Copyright © 2004–2010 All rights reserved. Anapol Schwartz. Read more information about Wellbutrin Lawsuits at www.anapolschwartz.com 4 Resources Bupropion Pregnancy Registry National Institute of Mental Health http://pregnancyregistry.gsk.com/documents/ bup_report_final_2008.pdf Extensive research of GlaxoSmithKline’s eleven year registry of the problems associated for women who took Wellbutrin and Zyban while pregnant or pre-pregnant. http://www.nimh.nih.gov/science-news/2006/ stopping-antidepressant-use-while-pregnantmay-pose-risks.shtml Depression is a disabling disorder that has been estimated to affect approximately 10 percent of pregnant women. What’s a pregnant woman to do? Children’s Heart Foundation http://www.childrensheartfoundation.org/ Research news, events, hopeful/heartbreaking stories, and fundraising awareness for parents, donors, and medical professionals about all things related to children with heart health problems Mayo Clinic—Congenital Heart Defects http://www.mayoclinic.com/health/congenitalheart-defects/DS01117 Important need-to-know information for every parent about congenital heart defects “WHAT IS THE PROBLEM WITH WELLBUTRIN?” Copyright © 2004–2010 All rights reserved. Anapol Schwartz. Read more information about Wellbutrin Lawsuits at www.anapolschwartz.com Wellbutrin http://www.wellbutrin.com/ GlaxoSmithKline website Zyban http://www.rxlist.com/zyban-drug.htm Everything you wanted to know about Zyban but were afraid to ask. Lots of warnings! 5
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