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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 in pregnant women has not been studied, but animal reproduction studies have resulted in fetal harm and were teratogenic. If rifapentine or rifampin are used in late pregnancy, coagulation should be monitored due to a possible increased risk of maternal postpartum hemorrhage and infant bleeding. [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]
Exposure to fetal blood cells that can cause RhD alloimmunization can happen during normal pregnancy and delivery, miscarriage, amniocentesis, cordocentesis, chorionic villus sampling, external cephalic version, or trauma. [3] [8] 92% of women who develop an anti-D during pregnancy do so at or after 28 weeks gestation. [11] [9] [12]
Tapentadol is pregnancy category C. There are no adequate and well-controlled studies of tapentadol in pregnant women, and tapentadol is not recommended for use in women during and immediately prior to labor and delivery. [31] There are no adequate and well-controlled studies of tapentadol in children. [31]
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The FDA lists chloroxine in Pregnancy Category C (risk cannot be ruled out) because no pregnancy studies on the medication have been performed with animals or humans. For this reason, use of chloroxine oral or topical during pregnancy or when breast-feeding is not recommended. [4]