Pregnancy Categories Medicine FDA

Pregnancy Medicine Category FDA

FDA Pregnancy Categories Medicine 

In 1979, the FDA established five letter risk categories – A,B,C,D or X – to indicate the potential of a drug to cause birth defect if used during pregnancy. The categories were determined by assessing the reliabiliy of documentation and the risk to benefit ratio. These categories did not take in account any risks from pharmaceutical agents or thier metabolites in breast milk. In the drug product label this information was found in the section ”Use in Specific Populations”.

The former pregnancy categories, which still may be found in some package inserts, were as follows;

Category A 

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is ni evidence of risk in later trimesters). Example:- Folic Acid, Levothyroxine, Iron, Calcium etc. 

  • Generally acceptable

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. Example:- Metformin, Amoxicillin, Hydrochlorthiazide, Paracetamol,Methyldopa etc.

  • May be acceptable

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 drug in pregnant women despite potential risks. Examples:- Chlormphenicol, Ciprofloxacin, Antipyschotics, Laxative, Amlodipine etc.

  • Use with caution, if benifit overweigh 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. Examples:- Losartan, Diazepam, Warfarin, Ethanol, Tetracycline, Anticonvulsants etc.

  • Use in life – threatening emergencies, when safer drugs can not be used

Category X 

Studies in animals or humans have demonstrated fetal abnormalities and /or there is positive evidence of human featl risk based on adverse reaction data from investigational or marketing experience, and the risk involved in use of the drug in pregnant women clearly outweigh potential benefits. Examples:- Methotrexate, Atrovastatin, Estradiol, Finasteride, Thalidomide etc. 

  • Don’t use in pregnancy – contraindicated, Risk involved outweigh potential benifits.
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