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FDA Draft
Guidance: Pregnant Women: Scientific and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.