Perspective

A Pediatrician’s Opinion on the Need for More Data on Medicines in Pregnancy

Susan P Tansey

Accepted November 8, 2019

Copyright © 2019 by Global Clinical and Translational Research.

This article is published under the virtual Special Issue of Prenatal, Fetal, Maternal, and Placental Drug Safety and Effectiveness.

How to cite this article:

Tansey SP. A pediatrician's opinion on the need for more data on more data on medicines in pregnancy. Glob Clin Transl Res. 2019; 1(4):129-130. DOI:10.36316/gcatr.01.0019.

References

1.      Alfirevic Z, Boer K, Borcklehurst P, Buimer M, Elbourne D, Kok J, et al. Two trials of antenatal thyrotropin-releasing hormone for fetal maturation: stopping before the due date. Antenatal TRH Trial and the Thyroneth Trial Groups. Br J Obstet Gynaecol. 1999;106(9):898-906.

2.      Jamieson DJ, Honein MA, Rasmussen SA, Williams JL, Swerdlow DL, Biggerstaff MS, et al. H1N1 2009 influenza virus infection during pregnancy in the USA. Lancet. 2009;374(9688):451-8.

3.      National Center for Immunization and Respiratory Diseases. General recommendations on immunization -- recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011; 60 (2):1-64.

4.      Bergin N, Murtagh J, Philip RK. Maternal Vaccination as an Essential Component of Life-Course Immunization and Its Contribution to Preventive Neonatology. Int J Environ Res Public Health. 2018;15(5).

5.      Barrett ADT. Current status of Zika vaccine development: Zika vaccines advance into clinical evaluation. NPJ Vaccines. 2018;3:24.

6.      https://www.gov.uk/government/news/valproate-banned-without-the-pregnancy-prevention-programme. Accessed on October 15, 2019.

7.      Hurault-Delarue C, Morris JK, Charlton R, Gini R, Loane M, Pierini A, et al. Prescription of antiepileptic medicines, including valproate in pregnant women: A study in three European countries. Pharmacoepidemiol Drug Saf. 2019.

8.      https://www.gov.uk/drug-safety-update/fingolimod-gilenya-increased-risk-of-congenital-malformations-new-contraindication-during-pregnancy-and-in-women-of-childbearing-potential-not-using-effective-contraception.Accessed on October 15, 2019.

9.      https://www.fda.gov/science-research/womens-health-research/pregnancy-registries. Accessed on October 15, 2019.

10.   FDA Draft Guidance: Pregnant Women:  Scientific and Ethical Considerations for Inclusion in Clinical Trials Guidance for Industry, April 2018, Revision 1.  https://www. fda.gov/media/112195/download.  Accessed on October 30, 2019.