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Antidepressant Birth Defects - 1-800-Law-Firm

About Depakote

Depakote and 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 may be used to treat other conditions as well. If you or a loved one were prescribed Depakote while pregnant and had a child with Spina Bifida, Cleft Palate or other birth defects, you may qualify for a cash settlement. . Please complete the form and one of our attorneys will contact you - or call 1-800-LAW-FIRM now! Depakote can cause severe birth defects when taken during pregnancy. Research has linked valproate sodium to Spina Bifida, other birth defects and cognitive problems in children. In December 2009, the FDA issued a warning to health care professionals regarding the risks for birth defects in babies exposed to valproate sodium. Results of a European 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. Valproate sodium is marketed as Depacon. Dilvalproex sodium is marketed as Depakote, Depakote CP, Depakote ER, Depakote DR, Depakote Sprinkles. Valproate sodium is marketed as Depakene and as Stavzor.

Cases, Settlements, & Verdicts

  • Paxil, Zoloft and Depakote antidepressants
  • 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
  • Reports of cleft palate, heart defects, limp abnormalities, spina bifida, and more
  • Paxil birth defect cases – As of July 2010, GlaxoSmithKline agreed to devote $1 billion to settle over 800 cases alleging birth defects
  • 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
Depakote Key Points

  • Used to treat seizure disorders, migraines, and bipolar disorder.
  • Causes Spina Bifida and cognitive problems in unborn children.
  • Causes two to 12 times the risk of severe birth defects in pregnant women.
  • Causes life-threatening liver failure and pancreatitis.
Conditions Caused By Depakote

  • Liver damage
  • Pancreatitis
  • Birth defects (especially if taken while pregnant)
  • Agitation, anxiety, restlessness (mental and physical)
  • Suicidal thoughts
  • Blood clots
Side Effects & Symptoms

  • Nausea
  • Vomiting
  • Stomach pain, or loss of appetite
  • Low fever
  • Dark urine
  • Clay-colored stools
  • Jaundice (yellowing of the skin or eyes)
  • Easy bruising, nosebleed, other abnormal bleeding
  • Dizziness, drowsiness, or blurred vision
  • Sun sensitivity
  • Mood and behavior changes
Warnings & Recalls

    In December 2009 the FDA 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.

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. Despite Paxil’s efficacy, the pharmaceutical has been proven to cause some serious side effects among its users. 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. If you or a loved one has experienced an adverse reaction while taking Paxil you may be entitled to a cash settlement. Please complete the form and one of our attorneys will contact you or call 1-800-LAW-FIRM now. 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.

Warnings & Recalls

  • In September 2004, FDA mandates black box warning on all anti-depressants (including Paxil) because of the increased risk of suicide in children and adolescents.
  • The FDA issued a safety advisory about Paxil in 2005, commenting on the potential relationship between the drug and birth defects when prescribed to pregnant mothers during the first trimester.
Cases, Settlements, & Verdicts

  • In October 2009, $2.5 million awarded to Pennsylvanian family for birth defects related to Paxil use while pregnant.
  • In June 2001, jury awards $8 million to the relatives of a man who killed himself along with 3 others while taking Paxil.
  • In 2010, GlaxoSmithKline settled more than a hundred Paxil birth defect lawsuits out of for an amount pushing into the billions of dollars. The cases involved children that developed birth defects after their pregnant mothers were prescribed Paxil. The settlement was structured so that GlaxoSmithKline in no way accepted the claim that Paxil was specifically responsible for the defects.
  • There are many more cases still pending against the manufacturers of Paxil.
Paxil Key Points

  • Prescribed to treat depression, obsessive-compulsive disorder, panic attacks and anxiety disorders.
  • In 2004 FDA mandates black box warning on all anti-depressants (including Paxil) because of the increased risk of suicide in children and adolescents.
  • In 2005, the FDA issued a safety warning for pregnant women regarding potential birth defects.
Conditions Caused By Paxil

  • Congenital Malformations/Birth Defects
  • Persistent Pulmonary Hypertension
  • Cardiac Malformations/Defects
Side Effects & Symptoms

  • Death
  • Difficulty Breathing
  • Seizures
  • Tremors
  • Shakiness
  • Premature Birth
  • Vomiting
  • Low Blood Sugar
  • Complications Requiring Emergency Surgery
About Zoloft

The FDA recognized studies documenting birth defects with the use of Selective serotonin reuptake inhibitors (SSRIs) known as anit depresants and issued a warning in 2005. Zoloft is one of three SSRIs the Mayo Clinic still lists as "Consider as an option during pregnancy." Although Paxil has very similar side effects it is currently recommend to be avoided. The Food and Drug Administration classifies Zoloft in the pregnancy class C and recommend 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. Medication use by pregnant woman in the first trimester increased by more than 60% in the past thirty years. A Boston University School of Public Health study also noted that many pregnant women are taking four or more medications. Anti depressant are the most commonly prescribed classes of medications with in the entire U.S. population. Johns Hopkins Bloomberg School of Public Health notes much of this growth was concentrated among people with less severe and poorly defined mental health conditions. Anti depressants are being prescribed as a catch all for various mental symptoms. Often patients including pregnant women are unnecessarily exposed to possible side effects and may not experience any proven health benefits. If you, or someone you know, has taken Zoloft while pregnant you may be entitled to a cash settlement. Please complete the form and one of our attorneys will contact you, or call 1-800-LAW-FIRM now.

Conditions Caused By Zoloft

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.

Warnings & Recalls

On December 8, 2005, the FDA issued a Public Health Advisory warning that use of certain antidepressants during the first trimester of pregnancy. U.S. and Swedish studies showed that exposure to certain antidepressants increased the risk of cardiac defects. 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.

Cases, Settlements, & Verdicts

There are several lawsuits against Pfizer the manufacturer of Zoloft. Average settlements are expected to exceed $1 Million for each family.

Zoloft Key Points

  • Pregnant women are taking four or more medications.
  • Food and Drug Administration recommends Zoloft only be used if the benefits greatly outweigh the possible risks.
  • Zoloft use by the expecting mothers has been associated with infant heart and lung malformations.
Side Effects & Symptoms

  • 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.

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