Document Detail

Use of tamoxifen before and during pregnancy.
MedLine Citation:
PMID:  22020212     Owner:  NLM     Status:  MEDLINE    
For premenopausal patients with receptor-positive early breast cancer, administration of tamoxifen for 5 years constitutes the main adjuvant endocrine therapy. During pregnancy, tamoxifen and its metabolites interact with rapidly growing and developing embryonic or fetal tissues. Information about tamoxifen and pregnancy was gathered by searching PubMed. In addition, we had access to the records of the pharmaceutical company AstraZeneca. Because these observations are retrospective and other therapies and diagnostic measures are possible confounders, a causal relationship was not established between tamoxifen treatment and pregnancy outcome. The records from AstraZeneca documented three live births with congenital anomalies and four live births without congenital anomalies related to tamoxifen treatment before pregnancy. Tamoxifen therapy during pregnancy resulted in 16 live births with congenital malformations and a total of 122 live births without malformations. The 122 live births without malformations included 85 patients from a prevention trial that did not record a single anomaly, whereas the AstraZeneca Safety Database alone reported 11 babies with congenital malformations of 44 live births. Additionally, there were: 12 spontaneous abortions, 17 terminations of pregnancy without known fetal defects, six terminations of pregnancy with fetal defects, one stillbirth without fetal defects, two stillbirths with fetal defects, and 57 unknown outcomes. The relatively high frequency of severe congenital abnormalities indicates that reliable birth control during tamoxifen treatment is mandatory. After tamoxifen use, a washout period of 2 months is advisable based on the known half-life of tamoxifen. In case of an inadvertent pregnancy, risks and options should be discussed.
Geert Braems; Hannelore Denys; Olivier De Wever; Veronique Cocquyt; Rudy Van den Broecke
Publication Detail:
Type:  Journal Article; Review     Date:  2011-10-21
Journal Detail:
Title:  The oncologist     Volume:  16     ISSN:  1549-490X     ISO Abbreviation:  Oncologist     Publication Date:  2011  
Date Detail:
Created Date:  2011-11-30     Completed Date:  2012-06-13     Revised Date:  2013-06-27    
Medline Journal Info:
Nlm Unique ID:  9607837     Medline TA:  Oncologist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1547-51     Citation Subset:  IM    
Department of Gynecologic Oncology, Ghent University Hospital, Ghent, Belgium.
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MeSH Terms
Abnormalities, Drug-Induced / etiology*
Antineoplastic Agents, Hormonal / administration & dosage,  adverse effects*,  pharmacology
Breast Neoplasms / drug therapy*
Pregnancy Complications, Neoplastic / drug therapy*
Pregnancy Outcome
Tamoxifen / administration & dosage,  adverse effects*,  pharmacology
Reg. No./Substance:
0/Antineoplastic Agents, Hormonal; 10540-29-1/Tamoxifen

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

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