LAB - 3 - FDA Preg.. Flashcards
A classification system used by the FDA to assess and communicate the potential risks of drugs when taken during pregnancy. These categories help healthcare providers and pregnant women make informed decisions regarding drug use.
FDA Pregnancy Categories
The FDA Pregnancy Categories
Category A
Category B
Category C
Category D
Category X
Adequate and well-controlled studies in pregnant women have not demonstrated a risk to the fetus during the first trimester, and there is no evidence of risk in later trimesters.
Category A
Examples: Prenatal vitamins, folic acid.
Category A
Animal studies have not demonstrated a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. Alternatively, animal studies have shown an adverse effect that was not confirmed in studies in pregnant women.
Category B
Examples: Aluminum hydroxide (Al-OH), Tagamet (cimetidine), Zantac (ranitidine), Loperamide, Roxithromycin, Insulin.
Category B
Animal studies have shown an adverse effect on the fetus, and there are no adequate and well-controlled studies in humans, but the potential benefits may justify the potential risks.
Category C
Examples: Lomotil, Dextromethorphan, Guaifenesin, Sedatives.
Category C
There is evidence of human fetal risk based on 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 D
Examples: Aspirin, Phenytoin, Lithium, Chemotherapeutic drugs.
Category D
Studies in animals or humans have demonstrated fetal abnormalities, and the risk of using the drug in pregnant women clearly outweighs any possible benefit.
Category X
Examples: Statins, Warfarin, Quinine, Benzodiazepines.
Category X
Not listed in a specific category, but historically known for causing severe birth defects when taken by pregnant women, leading to stricter regulations and more detailed assessments of drug safety during pregnancy.
Thalidomide
