Block 3 Lecture 1 -- Drugs and Pregnancy

Question 1

What factors influence the variance of outcomes of drug exposure on the fetus?

Answer 1

1) type of exposure
2) timing of exposure
3) dose/route/frequency
4) co-exposure
5) genetics

drugs can turn good bad

Question 2

Thalidomide’s currently approved uses:

Answer 2

multiple myeloma
pulmonary fibrosis
leprosy

Question 3

Preconception folate requirement

Answer 3

400 mcg

Question 4

When does organogenesis and cell differentiation occur?

Answer 4

GD20 - GD56

Question 5

What is spina bifida?

Answer 5

failure to zipper the neural tube

Question 6

Why is folic acid required?

Answer 6

bi-directional zippering of neural tube, which is derived from ectoderm

Question 7

FDA reproductive toxicity tests must be in:

Answer 7

rabbits + rats/mice at 3 doses

Question 8

Cat A

Answer 8

adequate controlled studies in pregnant women

– safe, no increased risk for fetal abnormalities

Question 9

Cat B

Answer 9

no evidence of harm in animal studies, or

ADRs in animals, but no evidence in controlled studies of pregnant women

Question 10

Cat C

Answer 10

ADRs in animal studies but no human studies, or

no studies in either

Question 11

Cat D

Answer 11

controlled or simple observational human studies show fetal harm

Question 12

Cat C

Answer 12

studies in animals or pregnant women demonstrate fetal abnormality
– may induce labor

Question 13

Cat C drugs

Answer 13

ASA (except for 3rd trimester)
NRT gum
Zyban
Chantix

Question 14

Cat D drugs

Answer 14

ACE-I, Li, phenytoin, carbamazepine, valproate, BZDs

nicotine patch

Question 15

Cat B drugs

Answer 15

APAP

Question 16

Problem with old pregnancy categories

Answer 16

give incorrect impression that all drugs in category are of similar risk

Question 17

What are the new pregnancy categorization?

Answer 17

3 sections of narrative form

• • Clinical Management Statement
• • Summary Risk Assessment
• • Discussion of Animal and Human Data

Question 18

What are the required components of the adverse developmental outcomes statemetn?

Answer 18

1) structural abnormalities
2) embryo
3) functional impairment
4) alterations to growth

Question 19

What is the new rule on risk statements?

Answer 19

1) human data
2) animal data
3) pharmacological considerations

in that order

Question 20

What are the old labeling categoreis

Answer 20

pregnancy
labor and delivery
nursing mothers

Question 21

What are the new labeling categories?

Answer 21

pregnancy
lactation
females and males of reproductive potential

Question 22

Why is nicotine patch in Cat D?

Answer 22

associated with premature labor and delivery

Question 23

What were the effects of prenatal oral nicotine administration in mice?

Answer 23

1) upregulation of nAChRs in SN and VTA
- - long-term development changes
- - tolerance in striatum
- - sensitaization in hippocampus
2) more likely to use nicotine
3) PNE-induced hyperactivity present in males (late) and females (early)
- - passed to offspring via female

Question 24

Describe nicotine’s distribution affecting the baby.

Answer 24

Readily crosses placenta

accumulates in amniotic fluid

Question 25

How does rat/mice development in utero differ from that of humans?

Answer 25

1) rat/mice have post-natal CNS growth spurt

2) human brain develops into teens

Question 26

How does birth weight correlate with CNS dysfunction?

Answer 26

it does not

Question 27

What are the effects of nicotine exposure in utero?

Answer 27

out of sequence ACh-regulated events

• • block apoptosis
• • increases neurotrophin synthesis
• • upregulates a4
• • increases nAChR density

Question 28

What does ACh regulate in utero?

Answer 28

neuron growth
neuron migration
synaptogenesis

Question 29

When does ACh release begin in utero?

Answer 29

GD18

Question 30

What are smoke exposure’s effects on the neonate?

Answer 30

1) +stillbirths, SIDS, tremor
2) growth retardation
3) ANS dysfunction
4) impaired pulmonary development
5) impaired orientation to senses
6) nicotine withdrawal syndrome?

Question 31

What are smoke exposure’s effects on teens?

Answer 31

1) pulmonary dysfunction: asthma, allergy
2) behavioral disorders
- - 2x as likely to commit felony
3) impaired cognitive developemnt

Question 32

What is the most preventable cause of mental retardation?

Answer 32

Alcohol, the only rec drug to be a teratogen

Question 33

What are the facial features of FASD?

Answer 33

short palpebral fissures
indistinct philtrum
thin upper lip

Question 34

How is FASD diagnosed?

Answer 34

1) maternal EtOH
2) growth deficiency, small head
3) CNS issues
4) facial features