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Investigators at Center for Health Studies publish new data on drug safety
November 19th, 2007
2007 NOV 19 -- Data detailed in 'Risks of congenital malformations and perinatal events among infants exposed to antidepressant medications during pregnancy' have been presented. In this recent study, researchers in the United States conducted a study "To evaluate risks for perinatal complications and congenital defects among infants exposed in utero to antidepressants We identified 2201 women who were prescribed an antidepressant during pregnancy and who delivered an infant within one of five large managed care organizations (HMO). Prescription drug dispensings and inpatient and outpatient diagnoses were obtained from automated databases at each HMO." "Antidepressants were categorized into tricyclic antidepressants (TCAs) or selective serotonin reuptake inhibitors (SSRIs), and medication timing was assessed by trimester. Rates of congenital anomalies or perinatal complications were compared to infants whose mothers were not prescribed antidepressants during pregnancy Infants exposed to SSRIs or TCAs during pregnancy had a significant increase in preterm delivery risk. Fullterm infants exposed to SSRIs during the third trimester had an increased risk for respiratory distress syndrome, endocrine and metabolic disturbances, hypoglycemia, temperature regulation disorders, and convulsions. Third-trimester exposure to TCAs was also associated with an increased risk for respiratory distress syndrome, endocrine and metabolic disturbances, and temperature regulation disorders. There were 182 infants exposed to Paroxetine, and these infants did not have an increased risk of cardiac septal defects SSRIs and TCAs did not show a consistent link with congenital anomalies. Paroxetine exposure was not linked with an increased risk for cardiovascular anomalies, although our study power to detect a moderate increase in risk was limited. Infants exposed to antidepressants were at increased risk for preterm delivery," wrote R.L. Davis and colleagues, Center for Health Studies. The researchers concluded: "Both SSRIs and TCAs used during the third trimester appeared to increase the risk for perinatal complications and their use should be managed carefully among pregnant women with depression." Davis and colleagues published their study in Pharmacoepidemiology and Drug Safety (Risks of congenital malformations and perinatal events among infants exposed to antidepressant medications during pregnancy. Pharmacoepidemiology and Drug Safety, 2007;16(10):1086-94). For more information, contact R.L. Davis, Center for Health Studies, Group Health Cooperative, Seattle, WA USA.. Publisher contact information for the journal Pharmacoepidemiology and Drug Safety is: John Wiley & Sons Ltd., the Atrium, Southern Gate, Chichester PO19 8SQ, W Sussex, England. Keywords: United States, Seattle, Antidepressant, Drug Development, Drug Safety, HMO, Health Insurance, Health Maintenance Organizations, Obstetrics, Pediatrics, Pharmaceuticals, Pharmacoepidemiology, Pregnancy, Therapy, Treatment. This article was prepared by Anti-Infectives Week editors from staff and other reports. Copyright 2007, Anti-Infectives Week via NewsRx.com.
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