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One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of high-quality data on a pharmaceutical for it to be defined as Pregnancy Category A. As a result of this, many drugs that would be labelled as safe in other countries are allocated to Category C by the FDA.
Pregnancy category C: safety in pregnant women has not been established. [1] Data is limited, and there is only one case report that notes no complications with the use of repaglinide during pregnancy. [3] Caution should be taken in people with liver disease and decreased kidney function when using this medication. [1]
Topical nicotinamide and topical zinc are safe, however, there are no FDA pregnancy category ratings. [27] [28] Topical salicylic acid and topical dapsone are classified as FDA pregnancy category C. [23] [28] Acne medications to avoid during pregnancy include oral isotretinoin and topical tazarotene as there have been reports of birth defects.
Rifapentine has been assigned a pregnancy category C by the U.S. Food and Drug Administration (FDA). Rifapentine in pregnant women has not been studied, but animal reproduction studies have resulted in fetal harm and were teratogenic.
Nicotine gum is designated pregnancy risk category C by the US Food and Drug administration, indicating that while animal studies have demonstrated an adverse effect on the fetus, there is an absence of adequate and well-controlled studies in pregnant women.
Belatacept, sold under the brand name Nulojix, is a fusion protein composed of the Fc fragment of a human IgG1 immunoglobulin linked to the extracellular domain of CTLA-4, [2] which is a molecule crucial in the regulation of T cell costimulation, selectively blocking the process of T-cell activation.
Aliskiren (brand names Tekturna and Rasilez) is the first in a class of drugs called direct renin inhibitors.It is used for essential (primary) hypertension. [2] While used for high blood pressure, other better studied medications are typically recommended due to concerns of higher side effects and less evidence of benefit.
The FDA originally labeled rabeprazole as a pregnancy category B drug (meaning that in vivo research failed to demonstrate a fetal hazard, though human studies are lacking), [17] but it was reclassified as a pregnancy category C drug (meaning that in vivo research has shown a fetal hazard, though the benefit of use may outweigh the risk) in 2014.