Pregnancy-Breastfeeding

Question 1

What FDA drug reviewer stopped Thalidimide from reaching the US?

Answer 1

Francis Kelsie

Question 2

Define Teratogen

Answer 2

Any agent that acts during embryonic or fetal development to produce a permanent alteration of form or function

Question 3

Define Hadegen

Answer 3

agent that alters normal maturation or function of an organ

Question 4

Define Trophogen

Answer 4

agent that alters growth

Question 5

Criteria for a teratogen

Answer 5

Defect thoroughly characterized

Agent must cross the placenta

Biologically plausible association

Consistent epidemiological findings

Suspected agent causes a defect in an animal

Exposure must occur during a critical development period

Question 6

Category A

Answer 6

Safe drugs (less than 1%)- levothyroxine, nistatin, pre natal vitamins, potassium supplements

Question 7

Category B

Answer 7

animal reproduction studies show no evidence of harm

Question 8

Category C

Answer 8

animal studies show that drug is teratogenic

Question 9

Category D

Answer 9

Drug can cause harm to when administered to a pregnant woman

Question 10

Category X

Answer 10

Drug is contraindicated in women who are or may become pregnant.

Question 11

Downsides to the Category drug list?

Answer 11

Drugs in categories D and X (and even C) may carry similar risks

Implies that all drugs in a category carry the same risk

Question 12

What are some mechanisms of birth defects?

Answer 12

Disruption of folic acid metabolism

Fetal genetic composition

Homeobox genes

Paternal exposure

Question 13

What are homeobox genes?

Answer 13

Genes that have to activate at a certain point, tells the fetus how to organize itself

Question 14

What drug can disrupt homeobox genes?

Answer 14

Retinoic acid

Question 15

What is the risk of a birth defect with no drugs?

Answer 15

3%

Question 16

What is the worst case risk of a birth defect with drugs?

Answer 16

6%

Question 17

What class of antibiotics can enter breast milk?

Answer 17

tetracyclines

Question 18

What time period may have a greater risk of drugs entering breast milk?

Answer 18

First few weeks of breastfeeding may be greater risk

Question 19

Characteristics of drugs that enter breast milk?

Answer 19

have to be non-ionized

low molecular weight

Lipid soluble drugs pass more freely

pH of plasma and milk

Question 20

Guidelines for women with a positive TOX screen for drugs of abuse

Answer 20

Breastfeeding can be supported in mothers who have:

• Abstained from the use of illegal drugs 90 days before giving birth
• Are enrolled, active and planning to continue in a substance abuse treatment program
• Have a negative drug screen at delivery
• Have received consistent prenatal care
• Have no other contraindications to breastfeeding