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A
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Controlled studies show no risk
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Adequate, well-controlled studies in pregnant women have failed to demonstrate risk to the foetus
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B
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No evidence of risk in humans
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Either animal findings show risk (but human findings do not) or, if no adequate studies have been done, animal findings are negative.
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C
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Risk cannot be ruled out
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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.
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D
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Positive evidence of risk
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Investigational or postmarking data show risk to foetus. Nevertheless, potential benefits may outweight the risk.
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X
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Contraindicated in pregnancy
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Studies in animals or humans, or investigational or postmarketing reports have shown foetal risk which clearly outweighs any possible benefit to the patient.
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