In the fall of 2005, GlaxoSmithKline released some information from their recently collected safety data indicating an increased risk of major congenital malformations among infants exposed during organ development to Paxil. Among 527 fetuses exposed to Paxil in the first trimester, 23 were born with major congenital malformations. Most of the malformations were cardiovascular, and the majority of those were ventricular septal defects (VSD). As compared with infants born to women taking any other antidepressant agent during the first trimester, the adjusted odds ratio for any malformation was 2.2, 1.3 to 3.6. Previously published studies were generally smaller and had not produced clear evidence.
Boston: The Slone Epidemiology Center at Boston University, the Genetics Unit, Massachusetts General Hospital for Children, and the Department of Epidemiology, Harvard School of Public Health assessed associations between first-trimester maternal use of SSRIs and the risk of birth defects among 9,849 infants with and 5,860 infants without birth defects participating in the Slone Epidemiology Center Birth Defects Study. Among outcomes previously reported to be associated with SSRI use, there were 127 cases of omphalocele, 115 cases of craniosynostosis, and 3,724 cases of congenital heart defects.
A SSRI used in combination with benzodiazipenes (examples are valium, Librium, Xanax, Atavan, etc.) increased the risk of Congenital Heart Disease (CHD) by 1.19 percentage points compared with no exposure. The risk difference remained statistically significant. SSRI alone (or monotherapy) did not increase the risk overall when compared with no exposure. The risk for ventral septic defect (VSD) did not increase with poly-drug exposure while the risk for atrial septic defect (ASD) increased with using SSRIs alone.
Clinical trials are not practiced on pregnant women.
Data is culled from pregnancy registries. In 6 of 7 studies comparing developmental outcomes of children exposed to antidepressants in utero with non-exposed children reported no significant differences. Most of these antidepressant medications remain relatively safe in pregnancy, but some significant areas of concern exist—particularly some evidence of higher risk of preterm birth, neonatal adaptation difficulties and congenital cardiac malformations (with Paxil).
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