USA Drug Categories
USA FDA Fetal Risk Categories
In the United States the government Food and Drug Administration (FDA) has established the following drug classification. See also Australian Drug Categories
FDA September 2014 - Discussion - anesthetic drugs to infants and young children
- Drugs Links: Australian Drug Categories | USA Drug Categories | Human Abnormal Development | BGD Tutorial
Some Recent Findings
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This table shows an automated computer PubMed search using the listed sub-heading term.
References listed on the rest of the content page and the associated discussion page (listed under the publication year sub-headings) do include some editorial selection based upon both relevance and availability.
Mary Regina Boland, Fernanda Polubriaginof, Nicholas P Tatonetti Development of A Machine Learning Algorithm to Classify Drugs Of Unknown Fetal Effect. Sci Rep: 2017, 7(1);12839 PubMed 28993650
Fantahun Molla, Admassu Assen, Solomon Abrha, Birhanetensay Masresha, Arega Gashaw, Abrham Wondimu, Yared Belete, Wondim Melkam Prescription drug use during pregnancy in Southern Tigray region, North Ethiopia. BMC Pregnancy Childbirth: 2017, 17(1);170 PubMed 28583106
Naichaya Chamroonkul, Teerha Piratvisuth Hepatitis B During Pregnancy in Endemic Areas: Screening, Treatment, and Prevention of Mother-to-Child Transmission. Paediatr Drugs: 2017; PubMed 28434087
Abiodun Idowu Adanikin, Jacob Olumuyiwa Awoleke Antenatal drug consumption: the burden of self-medication in a developing world setting. Trop Doct: 2016; PubMed 27302199
Jessica Ansari, Brendan Carvalho, Steven L Shafer, Pamela Flood Pharmacokinetics and Pharmacodynamics of Drugs Commonly Used in Pregnancy and Parturition. Anesth. Analg.: 2016, 122(3);786-804 PubMed 26891392
Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester, there is no evidence of a risk in later trimesters, and the possibility of fetal harm appears remote.
Either animal reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women, or animal reproduction studies have shown on adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of risk in later trimesters).
Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (eg, if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
- Leda L Ramoz, Nima M Patel-Shori Recent changes in pregnancy and lactation labeling: retirement of risk categories. Pharmacotherapy: 2014, 34(4);389-95 PubMed 24390829
- Michael Levine, Ayrn D O'Connor Obstetric toxicology: teratogens. Emerg. Med. Clin. North Am.: 2012, 30(4);977-90 PubMed 23137407
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Cite this page: Hill, M.A. 2018 Embryology USA Drug Categories. Retrieved January 16, 2018, from https://embryology.med.unsw.edu.au/embryology/index.php/USA_Drug_Categories
- © Dr Mark Hill 2018, UNSW Embryology ISBN: 978 0 7334 2609 4 - UNSW CRICOS Provider Code No. 00098G