Safety of Haloperidol and Penfluridol in Pregnancy: A Multicenter, Prospective, Controlled Study
J Clin Psychiatry 2005;66(3):317-322
© Copyright 2017 Physicians Postgraduate Press, Inc.
Purchase This PDF for $40.00
If you are not a paid subscriber, you may purchase the PDF.
(You'll need the free Adobe Acrobat Reader.)
Receive immediate full-text access to JCP. You can subscribe to JCP online-only ($86) or print + online ($156 individual).
With your subscription, receive a free PDF collection of the NCDEU Festschrift articles. Hurry! This offer ends December 31, 2011.
If you are a paid subscriber to JCP and do not yet have a username and password, activate your subscription now.
As a paid subscriber who has activated your subscription, you have access to the HTML and PDF versions of this item.
Click here to login.
Did you forget your password?
Still can't log in? Contact the Circulation Department at 1-800-489-1001 x4 or send email
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.