Pregnancy categories

Question 1

Category A

Answer 1

Controlled animal studies and studies in women have shown no risk in the first trimester and possible fetal harm is remote

Question 2

Category B

Answer 2

Either animal studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women OR animal studies have shown an adverse effect that was not confirmed in controlled studies in women in the first trimester

Question 3

Category C

Answer 3

No controlled studies in humans have been performed and animal studies have shown adverse events, or studies in humans and animals are not available. give only if potential benefit outweighs the risk

Question 4

Category D

Answer 4

Positive evidence of fetal risk is available. Benefits may outweigh the risk if life-threatening or serious disease

Question 5

Category X

Answer 5

Studies in animals or humans have shown fetal harm. Use in pregnancy is contraindicated

Question 6

General Rule

Answer 6

Try to avoid all drugs if possible in the first trimester (organogenesis) and use lifestyle changes first

Question 7

Common Teratogens

Answer 7

Alcohol, ACE inhibitors, ARBs, benzos, CBZ, ergot-derivatives, isotretinoin, leflunomide, Li, methimazole, naferlin, NSAIDs, paroxetine, phenytoin, phenobarbital, propylthiouracil, quinolone, ribavirin, tazarotene, tetracyclines, topiramate, VPA, misoprostol, methotrexate, statins, finasteide and dutasteride, warfarin, lenalidomide and thalidomide