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The Drug

Approved by the FDA in 1987, Prozac remains one of the most successful selective serotonin reuptake inhibitors (SSRIs) ever released on the market. As a class, SSRIs work by increasing the amount and availability of serotonin in the brain by blocking its reuptake. This increase is thought to have a corrective effect in patients with depressive symptoms, as research has shown depressed patients have significantly decreased levels of serotonin in the brain. In addition to treating major depression, Prozac has also been used to treat premenstrual dysphoric disorder, bulimia nervosa, panic and anxiety disorders, as well as obsessive compulsive disorder. In 2007, Prozac represented the third most popular antidepressant, with 22.2 million prescriptions filled.

The Controversy

Over the past two decades, a growing body of research has implicated SSRIs, including Prozac, as harmful to the development of infants during pregnancy. These concerns were first raised in 1996 by researchers at UCSD who found a link between third trimester exposure to Prozac, and perinatal complications. Specifically, these children exhibited an increased risk for persistent pulmonary hyptertension of the newborn (PPHN), as well as developing three or more minor abnormalities. These results were confirmed a decade later, when researchers found that mothers who took SSRIs in the second half of pregnancies were six times more likely to give birth to babies with PPHN. Because Prozac is easily passed from the mother to the child, either through blood or breast-feeding, the FDA has issued warnings that SSRIs should be used with caution during pregnancy. These concerns are further underscored by the estimated 80,000 women per year who take SSRI’s during pregnancy.

Some researchers have theorized that perhaps depression, rather than exposure to SSRIs, was responsible for the associated birth defects. This question was put to test by researchers in Canada, who compared birth outcomes between depressed mothers, and depressed mothers treated with SSRIs. Even when maternal illness was accounted for, exposure to SSRIs increased the risk of both low birth weight, and respiratory distress.

Other research suggests additional deleterious effects in children born of mothers taking SSRIs. Research out of Denmark suggests a causal link between SSRIs and cardiac malformations such as septal defects. In Israel, a study of thousands of mothers yielded data indicating that Prozac, taken during the first trimester, increased the risk of cardiovascular defects by one and a half, while doubling the risk of major abnormalities. Consequently, it would appear that regardless of the trimester in which the child is exposed, maternal consumption of Prozac during pregnancy can produce birth defects.

Finally, other studies have shown exposure to SSRIs during pregnancy doubles the risk of preterm delivery, increases the risk and time spent in a neonatal ICU, and produces symptoms of jaundice, seizures, respiratory problems, and withdrawal in infants. In addition, neurobehavioral and developmental deficiencies, such as motor defects, heart rate variability, and variances in sleep states have also been shown as disturbed by SSRI exposure.

The following symptoms and afflictions have been associated with SSRI use during pregnancy and may require surgery and/or treatment both at birth, and later in life.

  • Peripheral arterial disease
  • Congenital heart defects
  • Persistent pulmonary hypertension of the newborn
  • Serious withdrawal symptoms
  • Difficulty breathing requiring a ventilator
  • Anencephaly: absence of the brain and/or skull
  • Craniosynostosis: closing of the infants head before the appropriate time, leading to malformation of the skull
  • Omphalocele: a birth defect in which the infant’s intestine or other abdominal organ protrude out of the belly button

Symptoms

The following symptoms and afflictions have been associated with SSRI use during pregnancy and may require surgery both at birth, and later in life.

  • Peripheral arterial disease
  • Congenital heart defects
  • Persistent pulmonary hypertension of the newborn
  • Serious withdrawal symptoms
  • Difficulty breathing requiring a ventilator

If you or a loved one took Prozac during pregnancy and your child was born with a birth defect, please contact Kondos & Kondos today. Attorneys are available by phone, e-mail, or by clicking here.