Sertraline (Zoloft)

The Drug

Like Prozac and Paxil, Zoloft is classified as an antidepressant SSRI, or selective serotonin reuptake inhibitor.  These drugs exhibit their effects by increasing the amount of available serotonin in the brain, thus alleviating depressive symptoms.  As a result, Zoloft is primarily used for treating major depression, as well as panic disorders, social anxiety, and obsessive compulsive disorder.  Since its approval in 1991, Zoloft has exhibited extraordinary success in the market, and in 2007 was the most prescribed antidepressant on the market with over 29.6 million prescriptions filled.

The Controversy

Studies have shown that Zoloft can pass to neonates and newborns when taken by pregnant women, or via breastfeeding.  These exposure levels can reach 1/3 of the maternal exposure in utero.  Consequently, it is not too surprising that a drug with such bioavailability in an unborn developing child might produce birth defects.

Birth defects associated with Zoloft exposure are wide-ranging and diverse.  For example, research published in the New England Journal of Medicine has shown exposure to Zoloft during pregnancy can produce a six-fold increase in omphalocele (inability to properly form an abdominal wall), a four-fold increase in limb reduction defects, and craniosynostosis (malformed skull) [1,2].

While some disagreement does exist regarding the incidents of the aformentioned defects, there is greater agreement in the literature suggesting that Zoloft impedes the development of the heart, resulting in septal and atrial heart defects[3,4,5].  Furthermore, persistent pulmonary hypertension of the newborn (PPHN), wherein the newborns circulation system doesn’t adapt to breathing outside the womb, is also associated with in utero exposure to Zoloft[6].  As a result, the FDA issued a warning in 2006 that SSRIs should be used with caution during pregnancy[7].

Finally, data exists supporting the assertion that Zoloft increases the chances of premature birth by 8%[8] to 17%[9] (as compared to those taking no drugs during pregnancy), decreases birth weight[10], and may produce abnormal neurobehavioral outcomes, even in otherwise healthy, full-birth-weight infants[11].

Symptoms

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.

  • 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.
  • Anencephaly: absence of the brain and/or skull.
  • Neonatal abstinence syndrome: withdrawal.
  • Anal atresia: malformation of the anus.
  • Limb reduction.
  • Septal and atrial heart defects: holes in the heart.
  • Persistent pulmonary hypertension of the newborn after birth (PPHN).
  • Seizures, respiratory difficulties, oxygen depletion in the blood, difficulty eating, irritability, inconsolable crying, tremors.

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

[1] Louik C, Lin A, Werler M, et al.  First-Trimester Use of Selective Serotonin Reuptake Inhibitors and the Risk of Birth Defects.  The New England Journal of Medicine, 2007, 356(26): 2675-83.

[2] Alwan S, Reefhuis J, Rasmussen S, et. al.  Use of Selective Serotonin-Reuptake Inhibitors in Pregnancy and the Risk of Birth Defects.  The New England Journal of Medicine, 2007, 356(26): 2684-92.

[3] Id.

[4] Kornum J, Nielsen R, Pedersen L, et. al.  Use of Selective Serotonin-Reuptake Inhibitors During Early Pregnancy and Risk of Congenital Malformations: Updated Analysis.  Clinical Epidemiology, 2010, 2: 29-36.

[5] Pedersen L, Henriksen T, Vestergaard M, et. al.  Selective Serotonin Reuptake Inhibitors in Pregnancy and Congenital Malformations: Population Based Cohort Study.  British Medical Journal, 2009; 339:b3569.

[6] Chambers C, Hernandez-Diaz S, Van Marter L, et. al.  Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn.  The New England Journal of Medicine, 2006, 354(6): 579-587.

[7] U.S. Food and Drug Administration.  Public Health Advisory: Treatment Challenges of Depression in Pregnancy and the Possibility of Persistent Pulmonary Hypertension in Newborns.  July 19, 2006.

[8] Wen S, Yang Q, Garner P, et. al.  Selective Serotonin Reuptake Inhibitors and Adverse Pregnancy Outcomes.  American Journal of Obstetrics and Gynecology, 2006, 194(4):961-66.

[9] Wisner K, Sit D, Hanusa H, et. al.  Major Depression and Antidepressant Treatment: Impact on Pregnancy and Neonatal Outcomes.  American Journal of Psychiatry, 2009, 166:557-566.

[10] Wen S, Yang Q, Garner P, et. al.  Selective Serotonin Reuptake Inhibitors and Adverse Pregnancy Outcomes.  American Journal of Obstetrics and Gynecology, 2006, 194(4):961-66.

[11] Zeskind P & Stephens L, Maternal Selective Serotonin Reuptake Inhibitor Use During Pregnancy and Newborn Neurobehavior.  Pediatrics, 2004, 113(2): 368-75.

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