Drug use During Pregnancy Flashcards
What are 4 physiological changes in a pregger woman that influence the effect of drugs on the body?
- GI changes: decrease gastric acid secretion, high pH
- CV changes: plasma volume expansion, increased cardiac output (which influences change in drug distribution and elimination)
- Blood composition: decreased albumin levels (changed binding of drugs)
- Renal changes: increased blood flow and increased GFR (increased renal clearance of drugs)
What are the changes in hepatic enzyme activity in pregger women?
Increased metabolism by CYP3A4, CYP2D6 (often need more drugs to get same effect. Example: methadone)
Caudal regression syndrome is associated with what disorder?
Maternal diabetes mellitus.
Thalidomide’s significance?
This drug was tested in dogs, which metabolize drugs differently than we do. The dogs were fine, but in humans it caused severe limb abnormalities in children (there was specific link between time of exposure and defect). This taught us that the placenta is not a barrier, we need to pick our testing animal carefully and that there is a precise relationship between time of exposure to drug and the defect
FDA category A drug
Category A: No risk, human studies done
FDA category B drug
Category B: Animal studies show no risk but no human studies OR animal studies show increased risk and human studies show no risk.
FDA category C drug
Category C: Animal studies show increased risk, no human studies OR no human or animal studies
FDA category D drug
Category D: Proven risk for humans, but benefits may outweigh risks
FDA category N drug
Category N: Drug is not classified
FDA category X drug
Category X: Proven risk for humans, animals or both, risks outweigh benefits.
Example of Category A drug
Prenatal vitamins, T4
Example of Category B drugs
Penicillin or Acetaminophen
Example of Category C drugs
Nifedipine, Sumatriptan (migraine meds) Lamotrigine
Example of Category X drug
Warfarin
What category do ACE inhibitors fall under?
C and D
Example of Category D drug
Valproic acid