May 30 2020

MEDICINES DURING PREGNANCY




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MEANING OF CATEGORIES

Category A

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

Category B

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

Category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

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The information contained in this website does not replace professional advice and guidance from the attending physician, to whom you should consult before making decisions about your health problems. MEDIZZINE cannot warrant or assume any responsibility for the accuracy or comprehensiveness of the information provided. Conversely, MEDIZZINE recognizes that the information provided is not exhaustive and, therefore, does not expose all of the available information and, in any case, cannot replace information and criteria that your doctor may provide you.