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.
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
Janki Bhakta, Jacquelyn Bainbridge, Laura Borgelt Teratogenic medications and concurrent contraceptive use in women of childbearing ability with epilepsy. Epilepsy Behav: 2015, 52(Pt A);212-217 PubMed 26460786
Adam C Urato Are the SSRI antidepressants safe in pregnancy? Understanding the debate. Int J Risk Saf Med: 2015, 27(2);93-99 PubMed 26410012
Juan F Mosley, Lillian L Smith, Megan D Dezan An overview of upcoming changes in pregnancy and lactation labeling information. Pharm Pract (Granada): 2015, 13(2);605 PubMed 26131048
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. 2017 Embryology USA Drug Categories. Retrieved February 28, 2017, from https://embryology.med.unsw.edu.au/embryology/index.php/USA_Drug_Categories
- © Dr Mark Hill 2017, UNSW Embryology ISBN: 978 0 7334 2609 4 - UNSW CRICOS Provider Code No. 00098G