Safety of Haloperidol and Penfluridol in Pregnancy: A Multicenter, Prospective, Controlled Study
J Clin Psychiatry 2005;66(3):317-322
© Copyright 2016 Physicians Postgraduate Press, Inc.
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Objective: To assess the safety of the
butyrophenone neuroleptics haloperidol and penfluridol
Method: The rate of major anomalies was compared
between a cohort of pregnant women counseled for gestational
exposure to haloperidol or penfluridol and a
control group counseled for nonteratogen exposure. This
multicenter, prospective, controlled study was conducted within
the European Network of Teratology Information Services (ENTIS)
and included women who contacted 1 of 4 teratology information
services for counseling between January 1989 and December 2001.
Results: We followed up on the outcomes of 215
pregnancies exposed to haloperidol (N = 188) or penfluridol (N =
27)--78.2% (of 206) were in the first trimester--and compared to
outcomes of 631 ENTIS controls. The rate of congenital anomalies
did not differ between the haloperidol/penfluridol-exposed group
and the control group (6/179 = 3.4% vs. 22/581 = 3.8%, p = .787).
No difference was found by limiting the analysis to those exposed
to butyrophenones during the first trimester. There were 2
cases of limb defects in the butyrophenone-exposed group (1 after
haloperidol and 1 after penfluridol exposure) and none in the
controls. A higher rate of elective terminations of pregnancy
(8.8% vs. 3.8%, p = .004), a higher rate of preterm birth (13.9%
vs. 6.9%, p = .006), a lower median birth weight (3155 g vs. 3370
g, p < .001), and a lower median birth weight of full-term
infants (3250 g vs. 3415 g, p = .004) were found in the
butyrophenone-exposed group compared to the controls.
Conclusion: This study suggests that haloperidol
and penfluridol do not represent a major teratogenic risk. Since
a possible association between butyrophenone exposure and limb
defects cannot be ruled out with this sample size, a level II
ultrasound with emphasis on the limbs should be considered in
pregnancies with first trimester exposure.