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