FDA Pregnancy Categories:

The FDA has established five categories to indicate the potential of a drug to cause congenital disabilities if used during Pregnancy. The categories are:

Category A: ( Safest drug in Pregnancy)

Adequate and well-controlled studies have failed to show a risk to the fetus in the first trimester of Pregnancy (and there is no evidence of risk in later trimesters).

Category B: ( Will have no teratogenic effects in future )

Animal reproduction studies have failed to demonstrate a risk to the fetus, and there are no adequate and well-controlled studies in pregnant women.

Category C: ( Have Teratogenic Effects, Need Physician’s Advice )

Animal reproduction studies have shown an adverse effect on the fetus, and there are no adequate and well-controlled studies in humans. Still, potential benefits may happen by using the drug in pregnant women despite potential risks.

Category D: ( Research is going on )

Studies in humans have shown positive evidence of human fetal risk, but potential benefits may happen by using the drug in pregnant women despite potential risks.

Category X: ( Strictly prohibited during Pregnancy)

Studies in animals or humans have demonstrated fetal abnormalities and human fetal risk. The risk involved in the use of the drug in pregnant women is higher than the potential benefits.
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