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Prozac (fluoxetine), one of the oldest and most widely-prescribed antidepressants in the world, is controversial when it is used during pregnancy because it may increase the risk of birth defects. Many women who had a child with a Prozac birth defect allege that drug-makers are not doing enough to warn about the risk. Schmidt & Clark, LLP provides legal assistance to women who need to file a Prozac lawsuit.

What is Prozac?

Prozac (fluoxetine) is an orally-administered selective serotonin reuptake inhibitor (SSRI) medication that treats depression, anxiety, panic, obsessive-compulsive disorder, and many other conditions. It was created by Eli Lilly & Co. in the 1970s and approved by the U.S. Food and Drug Administration (FDA) in 1987.

Prozac and Pregnancy

Prozac is a “Pregnancy Category C” drug, and the manufacturer warns that it should only be used during pregnancy if the potential benefits justify the risks to a fetus. In animal studies, Prozac was shown to adversely affect fetal development by decreasing weight and increasing the risk of death.

Prozac and Heart Defects

Several studies have linked Prozac to an increased risk of heart defects. The most recent study, published in Obstetrics and Gynecology in 2011, found that Prozac doubled the risk of “hole-in-the-heart” defects like ventricular septal defect. Researchers estimated that 105 children out of 10,000 were born with this heart defect.

In addition, the Prescribing Information for Prozac warns about a European study linking first-trimester use of Prozac to an increased risk of cardiovascular malformations compared to babies who were not exposed to Prozac. However, drug-makers still defend the safety of Prozac, saying “a causal relationship has not been established.”

Prozac and Third Trimester Birth Defects

Prozac passes through the placenta and it may have a direct toxic effect on a developing baby. Women who take Prozac during the third trimester (last three months) of pregnancy can have a baby with severe withdrawal complications that may require prolonged hospitalization, tube feeding, and respiratory support. Symptoms of these complications include:

  • Seizures
  • Vomiting
  • Low blood sugar
  • Problems feeding
  • Irritability
  • Constant crying
  • And more

Prozac and Persistent Pulmonary Hypertension of the Newborn (PPHN)

In 2006, the FDA issued a Safety Alert after a study in the New England Journal of Medicine linked the use of Prozac or other SSRI antidepressants after the 20th week of pregnancy to a six-fold increased risk of Persistent Pulmonary Hypertension of the Newborn (PPHN). This severe, life-threatening lung defect is fatal in approximately 10% of newborns.

Prozac Birth Defects

  • Heart defects
  • Atrial Septal Defect
  • Ventricular Septal Defect (VSD)
  • Tetralogy of Fallot
  • Transposition of the Great Arteries
  • Truncus Arteriosus
  • Persistent Pulmonary Hypertension of the Newborn (PPHN)
  • Craniosynostosis
  • Neural tube defects
  • Spina bifida
  • Anencephaly
  • Omphalocele
  • Gastroschisis
  • Pulmonary Atresia
  • Clubfoot
  • Diaphragmatic Hernia
  • Autism
  • Neonatal withdrawal syndrome
  • And more

Prozac Linked to Heart, Skull Defects: BMJ Study

July 10, 2015 – A study published this week in The BMJ (formerly the British Medical Journal) found a link between Prozac and birth defects of the heart wall and skull.

“Continued scrutiny of the association between SSRIs and birth defects is warranted,” the researchers said, “and additional studies of specific SSRI treatments during pregnancy are needed to enable women and their healthcare providers to make more informed decisions about treatment.” Click here to learn more.

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