Pregnancy Drugs Categories

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If you're pregnant or thinking about getting pregnant and want a healthy baby, then it's very important to avoid drug use during pregnancy.


The FDA has established five categories to indicate the potential of a drug to cause birth defects if used during pregnancy. The categories are determined by the reliability of documentation and the risk to benefit ratio. They do not take into account any risks from pharmaceutical agents or their metabolites in breast milk. The pregnancy categories are:
•    Category A:  Controlled studies show no risk or find no evidence of harm.
•    Example drugs or substances: levothyroxine, folic acid, magnesium sulfate, liothyronine

•    Category B:  Animal studies show no risks, but there are no controlled studies on pregnant women.
•    Example drugs: metformin, hydrochlorothiazide, cyclobenzaprine, amoxicillin, pantoprazole

•    Category C:  Animal studies have shown risk to the fetus, there are no controlled studies in women, or studies in women and animals are not available.
•    Example drugs: tramadol, gabapentin, amlodipine, trazodone, prednisone

•    Category D:  There is positive evidence of potential fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (i.e. life threatening condition to mother).
•    Example drugs: lisinopril, alprazolam, losartan, clonazepam, lorazepam

•    Category X:  Studies in animals or human beings have demonstrated fetal abnormalities, or there is evidence of fetal risk. The drug is contraindicated in women who are or may become pregnant.
•    Example drugs: atorvastatin, simvastatin, warfarin, methotrexate, finasteride.

Adapted from: fda.gov