Antidepressants

Birth Defects from Your Antidepressant?

Even under the healthiest circumstances, the transition into parenthood is never easy. When children are born with birth defects that could have been prevented, adjusting to the new phase of life can be that much more challenging.

If you took Depakote, Paxil or Zoloft while pregnant and your child developed birth defects, you may wish to explore your legal options.

About Depakote

Depakote (valproate sodium) affect chemicals in the body involved in causing seizures and is commonly used to treat various seizure disorders including epilepsy. Depakote is also prescribed to treat the manic phase of bipolar disorders (manic-depressive illness) and to prevent migraine headaches.

Depakote can cause severe birth defects when taken during pregnancy. Research has linked valproate sodium to Spina Bifida and other birth defects and cognitive problems in children.

In December 2009 the FDA (Food & Drug Administration) issued a warning to health care professionals regarding the risks for birth defects in babies exposed to valproate sodium. The FDA also required a patient Medication Guide to accompany every prescription of the drug. Results of a study demonstrated that women who took valproate sodium in early pregnancy had two to 12 times the risk of having a baby with one of six specific birth defects compared to women who did not take the drug. The American Academy of Neurology recommends avoiding the use of valproate sodium in pregnant women.

About Paxil

Paxil (also known as Paroxetine or Aropax) is an antidepressant known as a selective serotonin reuptake inhibitor (SSRI). Manufactured by GlaxoSmithKline, Paxil was approved by the FDA in the early 1990s. It is currently prescribed to treat various psychological disorders including depression, obsessive-compulsive disorder, panic attacks, and anxiety disorders. It is approved only for use in adults.

Evidence demonstrates that GlaxoSmithKline deliberately chose against adequately warning physicians and expectant mothers about the risk of birth defects when pregnant mothers took Paxil. Those birth defects include persistent pulmonary hypertension in newborn babies (PPHN) and heart defects, including holes in the heart and malformations.

In 2005, the FDA issued a safety warning for pregnant women stating use of Paxil put the fetus at risk for “congenital malformations, particularly cardiac malformations.” As a result, GlaxoSmithKline added new recommendations to the warnings sections of Paxil, and the drug is no longer recommended for women who are pregnant or planning to become pregnant.

About Zoloft

The FDA recognized studies documenting birth defects upon the use of selective serotonin reuptake inhibitors (SSRIs) and issued a warning in 2005. Zoloft is one of three SSRIs the Mayo Clinic still considers as “an option during pregnancy.” Paxil, also an SSRI drug, has very similar side effects and is currently recommend to be avoided. The FDA classifies Zoloft in the pregnancy class C and recommends it only be used if the benefits greatly outweigh the possible risks. Despite continuing evidence that this drug increases the risk of birth defects in children and several FDA warnings, Pfizer the manufacturer of Zoloft, has yet to warn patients of the possible danger.

Documented occurrences of malformation of the heart and lungs in the fetus or a type of heart and lung disorder called persistent pulmonary hypertension (PPHN) at birth may be associated Zoloft. PPHN can lead to complications and even death. Zoloft also may contribute to complications for babies exposed later in the pregnancy. At birth the baby may experience difficulty breathing or feeding, irritable mood and impaired or excessive muscle tone and movement. These reactions may be side effects to the drug or to the withdrawal of drug. There are several conditions that indicate that your baby may have heart or lung defects. Please call a doctor immediately if your baby is experiencing grayish-blue skin color, difficulty breathing, cold hands and feet, unusual drowsiness, inactivity, shortness of breath, fast breathing, poor eating habits, fatigue, blue tinge to the skin and lips or slow growth. Other, more serious symptoms include swelling in the legs and feet, abdomen, fluid retention, and rapid or irregular heartbeat, murmurs, shortness of breath, chest pain or loss of consciousness.

The FDA issued a Public Health Advisory for Zoloft and several other antidepressants on July 19, 2006, warning that taking these drugs during pregnancy could increase the risk of persistent pulmonary hypertension of the newborn. A study published in the New England Journal of Medicine in 2006 found that babies born to mothers who used an SSRI antidepressant in the second half of pregnancy were six times more likely to be born with this serious lung disorder. The New England Journal of Medicine documented a “significant association” between Zoloft and septal defects in a 2007 study. A septal defect is a congenital defect that affects the structures of the heart and can be life threatening. According to the study, mothers who took Zoloft during their pregnancy could double the risk of having an infant born with septal defects.

Birth Defects Linked to Antidepressants:

• Arterial Septal Defects and Ventricular Septal Defects (Hole in the Heart): Defects in which there is a hole between two chambers of the heart. Septal defects can lead to the improper circulation of blood, making the heart work overtime. Surgery is sometimes necessary to repair the defect and prevent future complications.
• Coarctation of the Aorta: A form of heart defect in which a narrowing of the aorta occurs. The heart needs to pump harder to force blood through the narrow part of the aorta. If Coarctation of the Aorta is not treated it may lead to heart failure and death.
• Hypoplastic Left Heart Syndrome (HLHS): A rare congenital defect in which the left side of the heart is severely underdeveloped. The right side of the heart is forced to pump blood to all the major organs and the rest of the body. This condition is treated with surgery or a complete heart transplant and requires constant care under a cardiologist.
• Pulmonary Atresia: A birth defect in which the pulmonary valve of the heart does not form properly. A solid sheet of tissue forms where the valve should be and blood cannot flow from the right side of the heart to the lungs to pick up oxygen. This condition requires immediate attention. Treatment options include heart catheterization, open-heart surgery, heart transplant, and in some cases, a lifetime of medication.
• Pulmonary Stenosis: A heart defect in which the pulmonary valve of the heart is malformed. The result of this condition is that the malformed valve slows the flow of blood from the heart to the lungs and may require corrective heart surgery.
• Ebstein Malformation (Ebstein’s Anomaly): A rare congenital defect in which the wall that separates the upper heart does not close completely. Less severe instances of this heart defect only require careful monitoring by a cardiologist but moderate to severe cases may require heart surgery.
• PPHN: A condition that occurs when an infant’s arteries to the lungs remain constricted after delivery, limiting the amount of blood flow to the lungs and therefore the amount of oxygen into the bloodstream.
• Spina Bifida: A serious defect resulting in surgery and a lifetime of suffering and special needs. There is good scientific evidence showing that serotonin and SSRIs adversely impact the complex processes by which neural crest cells form the neural tube.
• Tetralogy of Fallot: A heart defect usually characterized by a ventricular septal defect (hole in the heart), a right ventricular outflow tract defect such as pulmonary stenosis, and an overriding aorta. The result of this condition is usually cyanosis within the first year of life and open heart surgery is required.
• Tricuspid Atresia: A birth defect in which the tricuspid heart valve is missing or abnormally developed. The result of this birth defect is that blood can’t flow through the heart and into the lungs to pick up oxygen. The treatment for this condition is surgery, and in some cases, several surgeries to treat the defect.
• Transposition of the Great Vessels: A birth defect in which the pulmonary and aorta arteries of the heart are switched. This results in a shortage of oxygen in the blood. Treatment for this birth defect is corrective surgery and is usually performed within the first few weeks of life.

Cases, Settlements, & Verdicts

• There are several lawsuits against Pfizer the manufacturer of Zoloft. Average settlements are expected to exceed $1 million for each family.
• In October 2009, $2.5 million awarded to Pennsylvanian family for birth defects related to Paxil use while pregnant.
• In 2010, GlaxoSmithKline settled more than a hundred Paxil birth defect lawsuits out of for an amount pushing into the billions of dollars.
• Paxil birth defect cases – As of July 2010, GlaxoSmithKline agreed to devote $1 billion to settle over 800 cases alleging birth defects
• Depakote birth defect lawsuit, entitled Arrowood, et al. v. Abbott Laboratories, Inc., was filed in the Illinois Southern District Court on June 8, 2012 by 27 women.
• Zoloft birth defect cases – As of October 2013, Zoloft birth defects multidistrict litigation is Zoloft (Sertraline Hydrochloride) Products Liability Litigation, MDL No. 2342, in the U.S. District Court for the Eastern District of Pennsylvania
• Zoloft cases include over 430 lawsuits

Understand Your Legal Options

If you took antidepressants during your pregnancy and your child developed birth defects, let 1-800-LAW-FIRM fight for the justice and financial compensation your family deserves. Fill out the form on the sidebar or call 1-800-529-3476 now.