FDA Classification of Drugs in Pregnancy

Food & Drug Administration(FDA) Pregnancy Risk Medicines Categories

  • Each drug may be placed in a pregnancy risk category based on the FDA’s estimate of risk to the fetus
  • The categories range from A to X, signifying least to greatest fetal Risk

Category – A (Controlled studies show no risk)

Adequate, well-controlled studies with pregnant women have failed to demonstrate a risk to the fetus in any trimester of pregnancy

Category – B (No Evidence of risk in humans)

  • Adequate, well-controlled studies with pregnant women haven’t shown an increased risk of fetal abnormalities, or, in the absence of adequate human studies, animal studies show no fetal risk.
  • The chance of fetal harm is remote but remains possible

Category – C (Risk Can’t be Ruled Out)

  • Adequate, Well-controlled human studies are lacking, and animal studies have shown a risk to the fetus or are lacking as well
  • A chance of fetal harm exists if the drug is given during  pregnancy, but the potential benefits may outweigh the risk.

Category – D (Positive Evidence of Risk)

  • Studies in humans, or investigational or post marketing data, have shown fetal risk
  • Nevertheless, potential benefits from the drug’s use may outweigh risks
  • For example, the drug may be acceptable if needed in life-threatening situation or serious disease for which safer drugs can’t be used or are ineffective

Category – X (Contraindicated in pregnancy)

Studies in animal or humans, or investigational or post marketing reports, have shown positive evidence of fetal abnormalities or risks that clearly outweigh any possible benefits to the patient

Please Find out the FDA Pregnancy Risk categories of following drugs (Write in the Comment Box)

Atorvastatin

Levothyroxine

Gabapentin

Losartan

Metformin

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