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November 10, 1993

Psychotropic Medications During Pregnancy: Risk to the Fetus

Author Affiliations

Eli Lilly and Company Indianapolis, Ind

JAMA. 1993;270(18):2177. doi:10.1001/jama.1993.03510180047019

To the Editor.  —As of March 31, 1993, our fluoxetine pregnancy database contained 1103 prospectively reported pregnancies. Of these prospective reports, outcomes are available from 544 (59 from clinical trials and 485 from spontaneous reports) of the 761 pregnancies that had potentially reached term. This is a 71% follow-up rate. Of these 544 pregnancies, 91 were electively terminated. Spontaneous abortion was reported in 72 (15.9%). There were two stillbirths. Perinatal major malformations were reported in 13 (3.4%). These malformations were macrostomia, atrial septal defect, bilateral hydroceles, gastrointestinal anomaly, constricted band syndrome, intestinal blockage, ureteral disorder (two cases), trisomy 18, stubbed and missing digits, trisomy 21, abdominal wall defect (in one twin), and hepatoblastoma. Additionally, seven postperinatal malformations were reported. These were pyloric stenosis (two cases), arrhythmia, tracheal malacia (three cases), and volvulus.Although the fluoxetine-treated population may differ from the general population because of the concomitant use of medications, alcohol