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Pregnancy Category: Classification & Explaination

Pregnancy Category

Pregnancy categories are made by the FDA to assess and classify the pharmaceuticals used in the pregnancy. There are six major pregnancy categories laid down by the FDA to cover almost every available drug.

  • Pregnancy Category A – No risk found in controlled human studies – This category contains all of those drugs, Whose safety has been confirmed by the human controlled trials and there was no evidence of drug causing harm to the baby or the mother.
  • Pregnancy Category B – No risk found in studies – Those drugs whose animal studies have failed to demonstrate the safety in the animal studies are classified under this category. This category of drugs usually considered safe as there are no known adverse effects on the fetus or mother.
  • Pregnancy Category C – Risk associated with use – Drugs who are found to produce adverse effects in the animal studies, but there is no record of human studies and have potential benefits for the humans are classified under this category.
  • Pregnancy Category D – Positive evidence of risk – In this category, all those drugs are classified who have been shown severe adverse effects in human controlled trials. Despite the potential fatal side effects they may be used in some conditions where the risk outweighs those adverse side effects.
  • Pregnancy Category X – Contraindicated in pregnancy – Those drugs who have shown a possible fatal risk in the human controlled clinical trial are classified under this category. Even the potential risk outweighs the benefits of drugs.
  • Pregnancy Category N – This is the category where FDA enlists the drugs which are not yet tested by the FDA.

Classification of drugs in pregnancy category

Pregnancy Category NameDrugs
Pregnancy Category AThiamine, Pyridoxine, Isoniazid, Doxylamine, Dextromethorphan, Folic Acid, Senna, Bisacodyl
Pregnancy Category BAmoxicillin, Ampicillin, Ceftriaxone, Cefuroxime, Cefpodoxime, Azithromycin, Metronidazole, Meropenem, Acyclovir, Paracetamol, Indomethacine, Ketamine, Cyclobenzaprine.
Pregnancy Category CClotrimazole, Guaifenesin, Bismuth subsalicylate, Atropine, Calcium carbonate, Simethicone, Nizatidine, Butoconazole, Miconazole, Tioconazole.
Pregnancy Ctegory DGentamycin, Streptomycin, Kanamycin, Doxycycline, Hydroxychloroquine, Primaquine, Phenobarbital, Atenolol, Lisinopril, Aspirin, Warfarin, Cortisone, Ibuprofen, Losartan, Valsartan.
Pregnancy Category XOxytocin, Isotretinoin, Valproate, Methotrexate, Ribavirin, Triazolam, Riociguat.
Pregnancy Category NThis includes the drugs that has not yet been classified by the FDA.

Pregnancy and Lactation Labeling Final Rule (PLLR)

On June 30th 2015, Pregnancy and Lactation Labeling Final Rule (PLLR) was passed. According to this law, It is mandatory to add information about dosing and potential risks to the developing fetus in pregnancy subsection.

Lactation subsection will be replaced by the “Nursing Mothers” subsection. Which will include the safety profile of that particular drug in the lactating mothers.

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