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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.
[96] [97] [98] In 2014, however, the FDA has developed a "Pregnancy and Lactation Labeling Rule (PLLR)" which requires product labels to include specific information related to the safety and effectiveness of medications to pregnant and lactating women. This ruling has removed the requirement of stating pregnancy categories in prescription drug ...
[1] [2] The FDA has long worked to classify and license new medications. Its Drug Evaluation and Research Center categorizes these medications based on both their chemical and therapeutic classes. [3] In several major drug classification systems, these four types of classifications are organized into a hierarchy. [4]
The national drug code (NDC) is a unique product identifier used in the United States for drugs intended for human use. The Drug Listing Act of 1972 [ 1 ] [ 2 ] requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed ...
Use during pregnancy is of unclear safety. [13] [14] Lurasidone was first approved for medical use in the United States in 2010. [2] In 2013, it was approved in Canada and by the U.S. Food and Drug Administration (FDA) to treat bipolar depression, either as monotherapy or adjunctively with lithium or valproate.
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]
Cinacalcet has pregnancy category C in the US, meaning that adequate and well-controlled studies involving cinacalcet in pregnant women have not been done. [ 4 ] [ 1 ] Studies have not been done in lactating women; therefore, it is not known whether cinacalcet is excreted into human milk.
Opioids can cross both the placental and blood-brain barriers, which poses risks to fetuses and newborns exposed to these drugs before birth. This exposure to opioids during pregnancy can lead to potential obstetric complications, including spontaneous abortion, abruption of the placenta, pre-eclampsia, prelabor rupture of membranes, and fetal death.