On September 27, 2005, the FDA issued an alert to healthcare professionals and consumers as GlaxoSmithKline changed their warning label on Paxil (paroxetine) to include the risk of birth defects. The results of a recent study conducted by the two indicated an increased risk of babies born with birth defects, specifically cardiovascular defects or congenital malformations, in instances where the mother was taking Paxil during the first trimester of pregnancy.
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Paxil, as well as other SSRIs, has been linked to Persistant Pulmonary Hypertension in the Newborn (PPHN) - a devastating condition affecting the heart and lungs of newborn infants. Babies are unable to breath properly due to constricted blood vessels which cut off oxygen to the blood and cause damage to other organs such as brain and kidneys.
Even babies that receive treatment may not recover, and those that do may have long-term breathing problems.
Paxil is used by millions of people worldwide and generates more than $1 billion in annual sales. Paxil has been in the news previously for complaints of severe withdrawal symptoms and risks of suicidal behavior and increased violence in children and adolescents. Paxil is known as a Selective Serotonin Reuptake Inhibitor (SSRI).
The FDA warns physicians to carefully weigh the potential risks and benefits of prescribing or renewing Paxil prescriptions to women during pregnancy or while breast-feeding. It is important that all patients are aware of the side effects, risks, and treatment alternatives.
Paxil Prenatal Exposure Risks
Paxil has the potential to influence fetal development, resulting in congenital defects in newborns, and withdrawal symptoms that torment babies for days or weeks after birth. [
READ MORE]
What is Paroxetine
Paxil (paroxetine) is a class of medicines called selective serotonin reuptake inhibitors (SSRIs). It is used to treat:
- Depression
- Panic disorder
- Social anxiety disorder (SAD)
- Obsessive-coompulsive disorder (OCD)
- Posttraumatic stress disorder (PTSD)
- Generalized anxiety disorder (GAD) [READ MORE]
Paxil Q&A
- What is paroxetine?
- Does paroxetine cause birth defects?
- What should women do if they are pregnant and taking paroxetine?
- What if I am taking paroxetine and want to get pregnant?
- Should I switch to another antidepressant?[READ THE ANSWERS]
Paxil Alerts
[
UPDATES] on FDA Advisories and Safety Alters, GlaxoSmithKline Healthcare Professional Advisories and Health Organization Advisories.
Paxil Articles
Groups Warn Against Taking Paxil While Pregnant
Paxil, a drug marketed as a way to treat depression, may have caused a lot of suffering for families after fetuses exposed to the drug were born with birth defects. Women took Paxil while pregnant, believing professionals who told them that Paxil was perfectly safe.
Paxil, Birth Defects and Autism
Over the past few years, lawyersandsettlements has interviewed dozens of women who took Paxil during their pregnancy and whose babies were born with birth defects. During these interviews, many women told us that their children - usually about age three and upwards -- were also diagnosed with autism.
Paxil Caused PPHN, Grief and Guilt
An interview with Paxil Lawyer Karen Barth Menzies
Paxil Birth Defects - Mothers Must Consider The Risks
The Anguish Caused by Paxil
Paxil Delivered Death Certificate
Paxil's Deadly Side Effect
Paxil Makers Face Lawsuits Related to PPHN and Other Birth Defects
Paxil and PPHN: The risk of Birth Defects versus the risk of Depression
Paxil Delivers Guilt along with Birth Defects
Paxil Blamed for Broken Heart
Five Children Born with Severe Heart Defects after Moms take Paxil
Paxil was thought to be Safe
Glaxo Writing Checks Left and Right to Settle Paxil Legal Battles
Paxil: A Fatal Link to Coronary Birth Defects
Paxil, Pregnancy and Birth Defects
Birth Defects And Other Threats To Mom And Baby Associated With Paxil
Glaxo gets Hit with another Paxil Birth Defects Lawsuit
Paxil: A Mother's Anguish
Paxil linked to Cleft Lip
Birth Defects could have been Prevented
Paxil Category Warning too late for My Baby
Paxil: A Mother's Warning
GlaxoSmithKline Sued over Paxil Birth Defects
Paxil Warning: Baby at Risk
How Paxil can Ruin Lives
Paxil and Birth Defects
Paxil Heart Birth Defects
Paxil Prescribing Information
Paxil and Paxil Birth Defects in the News
APR-27-07: A judge will approve a $64 million class action settlement for parents with teens on
Paxil. [
STL TODAY: PAXIL]
DEC-28-06: The American College of Obstetricians and Gynecologists' Committee on Obstetric Practice, advise that
Paxil should be avoided "by pregnant women or women planning to become pregnant due to the potential risk of fetal heart defects, newborn persistent pulmonary hypertension, and other negative effects." [
BEST SYNDICATION: PAXIL BIRTH DEFECTS]
DEC-27-06: The American College of Obstetricians and Gynecologists' Committee on Obstetric Practice, advised that
Paxil should be avoided "by pregnant women or women planning to become pregnant due to the potential
risk of fetal heart defects, newborn persistent pulmonary hypertension, and other negative effects." [
OPED NEWS: PAXIL BIRTH DEFECTS]
DEC-01-06: Strong
warning issued against the use of Paxil by pregnant women or those who plan to become pregnant. [
NEWS INFERNO: PAXIL BIRTH DEFECTS]
NOV-30-06: Health Canada issued a warning that paroxetine
(Paxil), a widely prescribed
SSRI, causes malformations to the fetus. [
COMMON GROUND: PAXIL BIRTH DEFECTS]
NOV-30-06:Baum Hedlund's first
Paxil birth defect case is featured on CNN. [
CNN: PAXIL HEART BIRTH DEFECTS]
NOV-29-06: Obstetricians recommend that women
avoid Paxil if they are pregnant or planning on becoming pregnant, due to a potential heightened
risk for birth defects. [
FORBES: PAXIL BIRTH DEFECTS]
OCT-16-06: First
PPHN Paxil Birth Defect Lawsuit Filed - Child Born with Life-Threatening Persistent Pulmonary Hypertension (PPHN) Sues Paxil Maker. [
PRESS RELEASE: PAXIL PPHN] [
CIVIL COMPLAINT: PAXIL PPHN]
OCT-09-06: FDA says there may be a connection to Paxil and babies born with
persistant pulmonary hypertension. [
NEWS WITH VIEWS: PAXIL BIRTH DEFECTS]
SEP-10-06: Glaxo Promotes Mental Disorders - then Paxil. [
BEST SYNDICATION: PAXIL BIRTH DEFECTS]
SEP-07-06: Parents Enraged at Glaxo over
Paxil Birth Defects. [
BEST SYNDICATION: PAXIL BIRTH DEFECTS]
