title: Teratogenic drugs and their drug interactions with hormonal contraceptives.
abstract: The US Food and Drug Administration (FDA) Guidance for Industry-Drug Interaction Studies, recommends that a potential human teratogen needs to be studied in vivo for effects on contraceptive steroids.(1) This article highlights the need to evaluate the drug-drug interactions (DDIs) between drugs with teratogenic potential and hormonal contraceptives (HCs) during drug development. It also addresses the FDA's effort of communicating DDI findings in product labels to mitigate the risk of unintended pregnancy.
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: M R
authors.initials: MR
authors.lastname: Ahn
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: L
authors.initials: L
authors.lastname: Li
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: J
authors.initials: J
authors.lastname: Shon
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: E D
authors.initials: ED
authors.lastname: Bashaw
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: M-J
authors.initials: MJ
authors.lastname: Kim
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000517:prevention & control*; D017326:Clinical Trials, Phase III as Topic / Q000379:methods; D003276:Contraceptives, Oral / Q000493:pharmacokinetics*; D004347:Drug Interactions; D015507:Drugs, Investigational / Q000494:pharmacology*; D005260:Female; D006801:Humans; D011247:Pregnancy; D013723:Teratogens / Q000494:pharmacology*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D003276:Contraceptives, Oral; D015507:Drugs, Investigational; D013723:Teratogens