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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.
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.
Nifedipine is considered safe in pregnancy and breastfeeding. [5] Nifedipine was patented in 1967, and approved for use in the United States in 1981. [2] [6] [7] It is on the World Health Organization's List of Essential Medicines. [8] It is available as a generic medication. [2]
The FDA has labeled gadobutrol as pregnancy category C. Sufficient studies of gadobutrol in pregnant human females have not been conducted. However, other GBCAs have been shown to cross the placenta in humans and result in fetal exposure, but do not show adverse effects to the fetus. [8]
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.
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 ...
Pyrantel pamoate is considered a pregnancy category C drug for use during pregnancy for humans, but is in category A for canines and felines. Pyrantel is considered safe to use in nursing animals. [7]