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
; 103(8): 718-20, 2015 Aug.
Article
in En
| MEDLINE
| ID: mdl-26223007
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.Key words
Full text:
1
Database:
MEDLINE
Main subject:
United States Food and Drug Administration
/
Abnormalities, Drug-Induced
/
Lactation
/
Population Surveillance
/
Databases, Factual
/
Drug Labeling
/
Prescription Drugs
Type of study:
Etiology_studies
/
Prognostic_studies
/
Risk_factors_studies
/
Screening_studies
Limits:
Female
/
Humans
/
Pregnancy
Country/Region as subject:
America do norte
Language:
En
Journal:
Birth Defects Res A Clin Mol Teratol
Year:
2015
Type:
Article