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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.
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]
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.
Enoxaparin is a FDA pregnancy category B drug which means enoxaparin is not expected to cause harm to an unborn baby when used during pregnancy. [9] Enoxaparin does not cross the placenta therefore it is unlikely an unborn baby would be exposed to it. [9]
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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 ...
It is considered pregnancy category D in both the United States and Australia, meaning they have a probability of harming the fetus. [9] Around 16% of amikacin crosses the placenta; while the half-life of amikacin in the mother is 2 hours, it is 3.7 hours in the fetus. [ 14 ]