Table 3

FDA pregnancy categories
FDA pregnancy category Description Drug
B Animal studies have revealed no evidence of harm to the fetus; however, there are no adequate and well-controlled studies in pregnant women. Glatiramer acetate
Or
Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
C Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. IFN-β, natalizumab, fingolimod, dexamethasone, prednisolone, IVIG and cyclosporin A
Or
No animal studies have been conducted, and there are no adequate and well-controlled studies in pregnant women.
D Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective. Cyclophosphamide, azathioprine and mitoxantrone
X Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant. Methotrexate

Borisow et al.

Borisow et al. EPMA Journal 2012 3:9   doi:10.1186/1878-5085-3-9

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