Pregnancy outcome following gestational exposure to venlafaxine: a multicenter prospective controlled study.
OBJECTIVE
Because there are no studies available on the safety of venlafaxine during pregnancy, the authors' goal in this study was to determine whether venlafaxine increases the risk for major malformations.


METHODS
Data on 150 women exposed to venlafaxine during pregnancy in seven pregnancy counseling centers were compared with data from studies of pregnant women who 1) received selective serotonin reuptake inhibitor antidepressants (SSRIs) (N=150) and 2) who received nonteratogenic drugs (N=150).


RESULTS
Among the 150 women who were exposed to venlafaxine during pregnancy, 125 had live births, 18 had spontaneous abortions, and seven had therapeutic abortions; two of the babies had major malformations. There were no significant 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 pregnancy does not increase the rates of major malformations above the baseline rate of 1%-3%.
Einarson
A
A
The Motherisk Program, The Hospital for Sick Children, University of Toronto, Ontario, Canada. einarson@sickkids.on.ca
Fatoye
B
B
Sarkar
M
M
Lavigne
S V
SV
Brochu
J
J
Chambers
C
C
Mastroiacovo
P
P
Addis
A
A
Matsui
D
D
Schuler
L
L
Einarson
T R
TR
Koren
G
G
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology* / Q000209:etiology; D000022:Abortion, Spontaneous / Q000139:chemically induced / Q000453:epidemiology; D000032:Abortion, Therapeutic / Q000706:statistics & numerical data; D001724:Birth Weight / Q000187:drug effects; D003511:Cyclohexanols / Q000009:adverse effects* / Q000627:therapeutic use; D003866:Depressive Disorder / Q000188:drug therapy*; D005260:Female; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D018811:Maternal Exposure / Q000009:adverse effects; D008431:Maternal-Fetal Exchange; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011256:Pregnancy Outcome / Q000453:epidemiology; D011261:Pregnancy Trimester, First; D011446:Prospective Studies; D012307:Risk Factors; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D012907:Smoking / Q000009:adverse effects; D000069470:Venlafaxine Hydrochloride
D003511:Cyclohexanols; D017367:Selective Serotonin Reuptake Inhibitors; D000069470:Venlafaxine Hydrochloride