Document Detail

Safety of haloperidol and penfluridol in pregnancy: a multicenter, prospective, controlled study.
MedLine Citation:
PMID:  15766297     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To assess the safety of the butyrophenone neuroleptics haloperidol and penfluridol in pregnancy. 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.
Orna Diav-Citrin; Svetlana Shechtman; Shani Ornoy; Judy Arnon; Christof Schaefer; Hanneke Garbis; Maurizio Clementi; Asher Ornoy
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Publication Detail:
Type:  Clinical Trial; Controlled Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
Title:  The Journal of clinical psychiatry     Volume:  66     ISSN:  0160-6689     ISO Abbreviation:  J Clin Psychiatry     Publication Date:  2005 Mar 
Date Detail:
Created Date:  2005-03-15     Completed Date:  2005-04-28     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7801243     Medline TA:  J Clin Psychiatry     Country:  United States    
Other Details:
Languages:  eng     Pagination:  317-22     Citation Subset:  IM    
Israeli Teratogen Information Service, Jerusalem 91120, Israel.
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MeSH Terms
Abnormalities, Drug-Induced / diagnosis,  epidemiology*,  etiology
Antipsychotic Agents / adverse effects*,  therapeutic use
Birth Weight
Butyrophenones / adverse effects,  therapeutic use
Cohort Studies
Follow-Up Studies
Gestational Age
Haloperidol / adverse effects*,  therapeutic use
Infant, Newborn
Maternal Exposure / statistics & numerical data*
Maternal-Fetal Exchange
Penfluridol / adverse effects*,  therapeutic use
Pregnancy Complications / drug therapy*
Pregnancy Outcome / epidemiology
Pregnancy Trimester, First
Premature Birth / chemically induced,  epidemiology
Prospective Studies
Reg. No./Substance:
0/Antipsychotic Agents; 0/Butyrophenones; 26864-56-2/Penfluridol; 52-86-8/Haloperidol

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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