Investigation of Safety Information on Drugs Prescribed to Pregnant and Nursing Women

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  • Chiba Takeshi
    Department of Clinical Pharmaceutics and Pharmacy Practice, School of Pharmacy, Iwate Medical University Department of Pharmacy, Iwate Medical University Hospital
  • Maeda Tomoji
    Department of Pharmacology, Nihon Pharmaceutical University
  • Tairabune Tomohiko
    Department of Clinical Pharmaceutics and Pharmacy Practice, School of Pharmacy, Iwate Medical University Department of Pharmacy, Iwate Medical University Hospital
  • Kudo Kenzo
    Department of Clinical Pharmaceutics and Pharmacy Practice, School of Pharmacy, Iwate Medical University Department of Pharmacy, Iwate Medical University Hospital

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Other Title
  • 妊婦・授乳婦における医薬品の安全性に関する情報の現状調査
  • ニンプ ・ ジュニュウフ ニ オケル イヤクヒン ノ アンゼンセイ ニ カンスル ジョウホウ ノ ゲンジョウ チョウサ

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Abstract

Limited available information suggests that some drugs prescribed to pregnant and nursing women may influence the development of the mammary gland and the function of milk production during pregnancy and lactation, resulting in disturbance of breastfeeding.  The objective of the present study was to investigate the safety of these drugs, as well as to assess the presence of safety information regarding their effect on the fetus, the infant, mammary gland development and milk production, within the Ethical Drug Package Inserts (EDPI), the Drugs in Pregnancy and Lactation (DPL), and the Drugs and Lactation Database (LactMed).  Thirty-one drugs were prescribed to 24 pregnant women in Iwate Medical University Hospital.  None of these drugs provided information on the safety of the fetus in the EDPI, while 22 drugs provided this information in the DPL.  No information was provided in any of the 31 drugs regarding their influence on mammary gland development in the EDPI and DPL.  Sixteen drugs were prescribed to 40 nursing women in Iwate Medical University Hospital.  None of these drugs provided information regarding the safety of the infant in the EDPI, while this information was provided in the DPL of 10 drugs and in LactMed of 4 drugs, respectively.  No information regarding the effects on milk production was provided in the EDPI of any of the 16 drugs, while this information was present in the DPL for one drug and in LactMed for 4 drugs.  In conclusion, safety information of drugs about their potential adverse effects on the fetus and the infant, as well as on mammary gland development and milk production, should be included in multiple sources, including EDPI, DPL, and LactMed.  Notably, very few sources provide information on the influence of drugs on mammary gland development and milk production and this information should be enriched in future.

Journal

  • Iyakuhin Johogaku

    Iyakuhin Johogaku 19 (4), 195-204, 2018

    Japanese Society of Drug Informatics

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