Pregnancy outcome following gestational exposure to venlafaxine: A multicenter prospective controlled study

Objective. Because there are no studies available on the safety of venlafax ine during pregnancy, the authors' goal in this study was to determine whet her venlafaxine increases the risk for major malformations. Method. Data on 150 women exposed to venlafaxine during pregnancy in seven pregnancy counseling centers were compared with data from studies of pregna nt women who 1) received selective serotonin reuptake inhibitor antidepress ants (SSRls) (N=150) and 2) who received nonteratogenic drugs (N=150). Results: Among the 150 women who were exposed to venlafaxine during pregnan cy, 125 had live births, 18 had spontaneous abortions, and seven had therap eutic abortions; two of the babies had major malformations. There were no s ignificant differences between these women and the two comparison groups on any of the measures analyzed. Conclusions: These results suggest that the use of venlafaxine during pregn ancy does not increase the rates of major malformations above the baseline rate of 1%-3%.