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Table 1 FDA Pregnancy Categories.

From: Raltegravir use in special populations

Category

Interpretation

A

Controlled studies show no risk

 

Adequate, well-controlled studies in pregnant women have failed to demonstrate risk to the foetus

B

No evidence of risk in humans

 

Either animal findings show risk (but human findings do not) or, if no adequate studies have been done, animal findings are negative.

C

Risk cannot be ruled out

 

Human studies are lacking and animal studies are either positive for foetal risk or lacking as well. However, potential benefits may justify the potential risk.

D

Positive evidence of risk

 

Investigational or postmarking data show risk to foetus. Nevertheless, potential benefits may outweight the risk.

X

Contraindicated in pregnancy

 

Studies in animals or humans, or investigational or postmarketing reports have shown foetal risk which clearly outweighs any possible benefit to the patient.