Prescription drug use in pregnancy: more evidence of safety is needed
Article first published online: 30 APR 2012
© 2012 Royal College of Obstetricians and Gynaecologists
The Obstetrician & Gynaecologist
Volume 14, Issue 2, pages 87–92, April 2012
How to Cite
Please cite this paper as: Prescription drug use in pregnancy: more evidence of safety is needed. The Obstetrician & Gynaecologist 2012;14:87–92., , .
- Issue published online: 30 APR 2012
- Article first published online: 30 APR 2012
- anti-epileptic drugs;
- congenital malformation;
- Medicines and Healthcare products Regulatory Agency;
- US Food and Drug Administration
- Prescription drug use during pregnancy is prevalent, with 44–99% of women being prescribed medication during pregnancy.
- Pregnant women and their unborn children are considered a vulnerable population; recent public health scares, such as H1N1, have highlighted the need for more detailed research into medication use in pregnancy.
- The teratogenic risk of more than 80% of 468 drugs released in the USA over the last 20 years remains to be clarified.
- Maternal physiological changes during pregnancy can alter drug pharmacokinetics, with poorly understood effects, while placental transfer of medications may have unknown fetal consequences.
- There is an urgent need for further research into the adverse effects of drugs used in pregnancy.
- To know about the prevalence of prescription medication use during pregnancy.
- To be aware of the lack of safety data available on fetal adverse effects for commonly prescribed drugs.
- Drug companies are reluctant to carry out phase III clinical trials in pregnant women and they rely on animal models and post-marketing surveillance for the identification of adverse effects.
- Is it unethical to prescribe drugs in pregnancy for which there is little concrete safety data?