Teratogenesis, Pregnancy, and Postpartum Issues Flashcards
(150 cards)
What factors influence teratogenic potential?
- Duration of Use
- Susceptibility of Fetus
- Placental Transfer
- Timing of Exposure
What is the mechanism of Placental Transfer?
Passive Diffusion
What factors influence rate and extent of passive diffusion?
- MW
- Protein Binding
- Lipid Solubility
- Ionization
- Concentration Gradient
- Uterine Blood Flow
In terms of MW, what are the sizes that cross and do not cross the placenta?
<500 daltons, readily cross
>1000 daltons, do not cross in significant amounts
Do highly protein bound drugs cross the placenta?
NO
Ionized or Unionized drugs cross the placenta?
Unionized
The Pre-Embyronic Stage is 0-14 days after fertilization, what is the teratogen effect?
Teratogen exposure produces ALL or NOTHING effect
The Embryonic Stage is 14-56 days, what is the teratogen effect?
MOST Susceptible = MAJOR structural anomalies
The Fetal Stage is 57 days - term, what is the teratogen effect?
Anomalies more likely to involve growth and functional aspects
What are the limitations of the OLD FDA Categories?
Derived from animal data
No distinction between drugs in the same class
Majority in Category C
Lacks informative data
What does the REVISED FDA labeling include?
- Removed letter category
- Pregnancy Subsection
- Lactation Subsection
- Females and Males of Reproductive Subsection
What are agents to avoid DURING pregnancy?
- ACE/ARBs/Renin Inhibitors
- DOACs
- Isotretinoin
- NSAIDs
- Retinoids
- Thalidomide
- Trimethoprim
- Valproic Acid
- Warfarin
What is the concern with Thalidomide and does it have a REMs?
Contraindicated in Pregnancy
YES
What are the requirements for the REMS of Thalidomide?
- Prescription filled <7 days and no more than a 4-week supply at one time
- Patients required to use contraceptive measures
- Females must have neg pregnancy test within 24 hrs prior to starting treatment
What is the concern with Lenalidomide and does it have a REMs?
Contraindicated in pregnancy
YES
What is the concern with Retinoids?
Contraindicated in pregnancy
When is the greatest risk for Retinoids?
At 4-7 weeks gestation and risk persists after stopping therapy
What is the contraception requirement for Isotretinoin?
Contraception 1 month following DC
What is the contraception requirement for Acitretin (Soriatane)?
Contraception for 3 years following DC
What is the iPLEDGE Program?
REMs for Isotretinoin, requires all patients, prescribers, pharmacists, and wholesale distributors to register
For iPLEDGE patients must complete an informed consent with pick prescription within?
30 days for men and women who cannot get pregnant
7 days for women of childbearing potential
For females of childbearing potential, iPLEDGE requires what?
2 negative pregnancy tests before starting, negative pregnancy test every month, and use of 2 forms of contraception
Can you donate blood while taking Isotretinoin?
NO
How does the dating of pregnancy (gestation) work?
Gestation age refers to age of fetus beginning the first days of the last menstrual period which is ~2 weeks prior to fertilization