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The pregnancy category of a medication is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites in breast milk. Every drug has specific information listed in its product literature.
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
In several major drug classification systems, these four types of classifications are organized into a hierarchy. [4] For example, fibrates are a chemical class of drugs (amphipathic carboxylic acids) that share the same mechanism of action ( PPAR agonist ), the same mode of action (reducing blood triglyceride levels), and are used to prevent ...
Opioids are a class of drugs that include prescription painkillers (e.g., oxycodone, hydrocodone) and illicit substances like heroin. Opioid use during pregnancy is associated with an increased risk of complications, including an elevated risk of preterm birth, low birth weight, intrauterine growth restriction, and stillbirth. Opioids are ...
This ruling has removed the requirement of stating pregnancy categories in prescription drug labels. [99] Australia's categorization system takes into account birth defects, the effects around birth or when the mother gives birth, and problems that will arise later in the child's life due to the drug taken. The system places them into a ...
The drug or other substance has a high potential for abuse. The drug or other substance has no currently accepted medical use in treatment in the United States. There is a lack of accepted safety for use of the drug or other substance under medical supervision. The complete list of Schedule I substances is as follows. [1]
Data from studies conducted on women taking antiepileptic drugs for non-epileptic reasons, including depression and bipolar disorder, show that if high doses of the drugs are taken during the first trimester of pregnancy then there is the potential of an increased risk of congenital malformations.
The FDA pregnancy classification is removed from this infobox, and does not show any more. By FDA, it is replaced by the Pregnancy and Lactation Labeling Rule (PLLR) of December 2014. The PLLR is descriptive, and not suitable for this infobox. [1]