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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.
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.
In October 2020, the US Food and Drug Administration (FDA) required the prescription drug label to be updated for all nonsteroidal anti-inflammatory medications to describe the risk of kidney problems in unborn babies that result in low amniotic fluid. [20] [21] They recommend avoiding NSAIDs in pregnant women at 20 weeks or later in pregnancy ...
Ziprasidone was approved for medical use in the United States in 2001. [5] The pills are made up of the hydrochloride salt, ziprasidone hydrochloride. The intramuscular form is the mesylate , ziprasidone mesylate trihydrate, and is provided as a lyophilized powder.
The years-long effort to yank the drug's approval offers a case study of the agency's accelerated approval program, which green-lit Makena in 2011. Battle over pregnancy drug highlights risks of ...
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.