USA Drug Categories: Difference between revisions
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In the United States the government Food and Drug Administration (FDA) historically (before 2015) established the drug labelling classes (A, B, C, D, and X) to define their safety. Since 2015 this drug classification has been replaced with the "FDA Pregnancy and Lactation Labeling Rule" (PLLR).{{#pmid:27904304|PMID27904304}} | In the United States the government Food and Drug Administration (FDA) historically (before 2015) established the drug labelling classes (A, B, C, D, and X) to define their safety. Since 2015 this drug classification has been replaced with the "FDA Pregnancy and Lactation Labeling Rule" (PLLR).{{#pmid:27904304|PMID27904304}} | ||
A 2011 study of USA data from 1976-2008 has shown:{{#pmid:21514558|PMID21514558}} | |||
* 6 million pregnancies every year | |||
* 50% of pregnant women reported taking at least one medication | |||
* Pregnant women take an average of 2.6 medications at any time during pregnancy | |||
* First trimester use of prescription medications has increased by more than 60% | |||
* Use of 4 or more medications in the first trimester has tripled (9.9% to 27.6%) | |||
Revision as of 09:07, 16 February 2018
USA FDA Fetal Risk Categories
In the United States the government Food and Drug Administration (FDA) historically (before 2015) established the drug labelling classes (A, B, C, D, and X) to define their safety. Since 2015 this drug classification has been replaced with the "FDA Pregnancy and Lactation Labeling Rule" (PLLR).[1]
A 2011 study of USA data from 1976-2008 has shown:[2]
- 6 million pregnancies every year
- 50% of pregnant women reported taking at least one medication
- Pregnant women take an average of 2.6 medications at any time during pregnancy
- First trimester use of prescription medications has increased by more than 60%
- Use of 4 or more medications in the first trimester has tripled (9.9% to 27.6%)
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Some Recent Findings
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FDA History
US FDA Historic Background | |
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Date | Events |
1906 | Food and Drugs Act is passed by Congress and prohibits interstate transportation of misbranded or adulterated foods, drinks, and drugs. |
1927 | Food and Drug Administration Agency is formed and given authority to enforce the Food and Drugs Act. |
1938 | Federal Food, Drug, and Cosmetic (FDC) Act is passed, requiring all drugs to have demonstrated safety prior to marketing. |
1951 | Durham-Humphrey Amendment established the category of prescription drugs and gave the FDA the power to determine if a drug should be prescription-only or over-the-counter. |
1962 | Kefauver-Harris Amendment passed after thalidomide was found to cause birth defects. It requires drug manufacturers to provide stronger evidence of safety and effectiveness prior to FDA approval for marketing. |
1966 | FDA issued requirement for animal studies referred to as “3-Segment Studies” to evaluate safety of drugs. The studies should be designed to address 1) fertility, 2) in utero development, and 3) perinatal and postnatal effects. |
1970 | FDA requires first package insert for women using oral contraceptives. |
1979 | As published in 1980, FDA establishes the ABCDX pregnancy risk categories and requires the packaging label to include one of these categories. |
1993 | FDA revises a policy that excluded women of childbearing potential from being participants in drug trials and requires improved assessments of medication responses specific to gender. |
2007 | New regulations are passed that require all studies of drugs that involve human participants to register with ClinicalTrials.gov.; some drugs to conduct postapproval studies or have a risk evaluation and mitigation strategy to monitor the drug once it is marketed; and package inserts to include contact information for reporting adverse reactions. |
2008 | FDA proposes changing the pregnancy labeling categories. |
2015 | Content and Format of Labeling for Human Prescription Drug and Biologic Products; Requirements for Pregnancy and Lactation Labeling (Final rule 79, FR 72064) is passed and requires the removal of the ABCDX labels from all prescription and biologic product labels and new requirements to include narrative descriptions. |
Table historic data[5] |
US FDA - Historic Drug Categories (pre-2015) | ||||||||||||||
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FDA Pregnancy and Lactation Labeling Rule
- "The PLLR requires changes to the content and format for information presented in prescription drug labeling in the Physician Labeling Rule (PLR) format to assist health care providers in assessing benefit versus risk and in subsequent counseling of pregnant women and nursing mothers who need to take medication, thus allowing them to make informed and educated decisions for themselves and their children. The PLLR removes pregnancy letter categories – A, B, C, D and X. The PLLR also requires the label to be updated when information becomes outdated."
- Links: Final Rule
Anesthetics
FDA September 2014 - Discussion - anesthetic drugs to infants and young children
References
- ↑ Pernia S & DeMaagd G. (2016). The New Pregnancy and Lactation Labeling Rule. P T , 41, 713-715. PMID: 27904304
- ↑ Mitchell AA, Gilboa SM, Werler MM, Kelley KE, Louik C & Hernández-Díaz S. (2011). Medication use during pregnancy, with particular focus on prescription drugs: 1976-2008. Am. J. Obstet. Gynecol. , 205, 51.e1-8. PMID: 21514558 DOI.
- ↑ <pubmed>24390829</pubmed>
- ↑ <pubmed>23137407</pubmed>
- ↑ Brucker MC & King TL. (2017). The 2015 US Food and Drug Administration Pregnancy and Lactation Labeling Rule. J Midwifery Womens Health , 62, 308-316. PMID: 28556499 DOI.
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Cite this page: Hill, M.A. (2024, June 16) Embryology USA Drug Categories. Retrieved from https://embryology.med.unsw.edu.au/embryology/index.php/USA_Drug_Categories
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