Citalopram (Celexa)

The Drug

Belonging to the class of anti-depressants known as selective serotonin reuptake inhibitors (SSRIs), Celexa operates by increasing the amount of available serotonin in the brain.  This mechanism of action presumably allows the drug to correct low levels of serotonin associated with depressed patients.  Consequently, its primary usage since FDA approval in 1989 has been for treatment of major depression.  Off-label uses (uses not approved by the FDA) include treatment of ADHD, premenstrual dysphoric disorder, obsessive compulsive disorder, as well as anxiety and panic disorders.

The Controversy

In 2006, researchers at the University of San Diego published data in the New England Journal of Medicine supporting an association between late-pregnancy maternal use of SSRIs, including Celexa, and the development of persistent pulmonary hypertension of the newborn (PPHN)[1].  In these infants, the normal physiological response required for infants to breath outside the womb is impeded, resulting in difficulty oxygenating blood.  This affliction is often fatal, and even if treated, may lead to neurological impairment.  In response to this report, the FDA issued a public safety advisory the same year, warning that the use of SSRIs during pregnancy may cause PPHN[2].

In addition to the risk of PPHN, other studies suggest that SSRIs impair cardiac development of the infant during pregnancy.  In one study involving almost 500,000 births out of Denmark, the authors concluded that mothers who were prescribed SSRIs during pregnancy had an increased chance of bearing an infant with septal heart defects, particularly with Celexa[3].   These results were later supported by a similar study concluding that maternal use of SSRIs early in pregnancy was associated with a 1.7 fold increase in the risk of congenital heart defects, with septal heart defects being the most predominant[4].

Research also suggests that the use of SSRIs during pregnancy may result in cognitive, behavioral, and physiological defects at birth.  For example, the use of SSRIs, including Celexa, resulted in lower birth weights, longer hospital stays, increased admissions to neonatal intensive care wards, and an increase in preterm births[5,6].  Physiologically, other reports suggest maternal SSRI use may result in a child born with craniosynostosis, anencephaly, omphalocele, and respiratory distress[7,8].  Finally, still other research indicates that even healthy, full-birth-weight infants exposed to SSRIs during pregnancy exhibit clinical features associated with neonatal withdrawal syndrome.  These same features, when exhibited by adults, are symptomatic of serotonin toxicity.  Sadly, these children were described by the authors as “tremulous, motorically erratic, underaroused and in an unchanging REM state[9].”

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

If you or a loved one took Celexa 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] Chambers C, Johnson, K, Dick L, et al.  Birth Outcomes in Pregnant Women taking Fluoxetine.  The New England Journal of Medicine, 1996, 335(14):1010-1015.

[2] 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.

[3] Pedersen L, Vestergaard M, Olsen J, Bech B.  Selective Serotonin Reuptake Inhibitors in Pregnancy and Congenital Malformations: Population Based Cohort Study.  British Medical Journal, 2009;339:b3569.

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

[5] Oberlander T, Warburton W, Misri S, et. al.  Neonatal Outcomes After Prenatal Exposure to Selective Serotonin Reuptake Inhibitor Antidepressants and Maternal Depression Using Population-Based Linked Health Data.  Archives of General Psychiatry, 2006, 63: 898-906.

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

[7] 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.

[8] Oberlander T, Warburton W, Misri S, et. al.  Neonatal Outcomes After Prenatal Exposure to Selective Serotonin Reuptake Inhibitor Antidepressants and Maternal Depression Using Population-Based Linked Health Data.  Archives of General Psychiatry, 2006, 63: 898-906.

[9] 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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