“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
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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.
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4
• What Is Zyban? Does Zyban have side effects? 4
• Should I File a Wellbutrin Heart Defect Lawsuit? 4
• Resources 5
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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.
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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
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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!
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