Assessing congenital malformation risk from medications used in pregnancy: The contribution of NBDPS in pregnancy labeling of prescription drug products

Birth Defects Res A Clin Mol Teratol. 2015 Aug;103(8):718-20. doi: 10.1002/bdra.23403. Epub 2015 Jul 27.

Abstract

Background: Obtaining human pregnancy data to inform product labeling is important for drug and biological products.

Methods: Collection and analyses of safety data on their use during pregnancy is usually performed after approval.

Results: The Centers for Disease Control National Birth Defects Prevention Study has provided important data on the relationship between drug use in pregnancy and birth defects.

Conclusion: The Pregnancy and Lactation Labeling Rule will set new and improved standards for the inclusion of information about the use of prescription drugs and biological products during pregnancy; the National Birth Defects Prevention Study, along with other data sources, will be critical for providing safety data to inform product labeling.

Keywords: FDA; NBDPS; pregnancy labeling.

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology
  • Abnormalities, Drug-Induced / etiology*
  • Abnormalities, Drug-Induced / prevention & control
  • Centers for Disease Control and Prevention, U.S.
  • Databases, Factual*
  • Drug Labeling / legislation & jurisprudence*
  • Female
  • Humans
  • Lactation / drug effects*
  • Population Surveillance*
  • Pregnancy
  • Prescription Drugs / adverse effects*
  • Risk Factors
  • United States / epidemiology
  • United States Food and Drug Administration / legislation & jurisprudence*

Substances

  • Prescription Drugs