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

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.

• Authors: Melissa S Tassinari, Leyla Sahin, Lynne P Yao
• Journal: Birth defects research. Part A, Clinical and molecular teratology (Birth Defects Res A Clin Mol Teratol) Vol. 103 Issue 8 Pg. 718-20 (Aug 2015) ISSN: 1542-0760 [Electronic] United States
• PMID: 26223007 (Publication Type: Journal Article)
• Copyright: © 2015 Wiley Periodicals, Inc.

Chemical References

• Prescription Drugs

Topics

• Abnormalities, Drug-Induced (epidemiology, etiology, 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)