Block 3 Lecture 1 -- Drugs and Pregnancy Flashcards Preview

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Flashcards in Block 3 Lecture 1 -- Drugs and Pregnancy Deck (34):
1

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

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

drugs can turn good bad

2

Thalidomide's currently approved uses:

multiple myeloma
pulmonary fibrosis
leprosy

3

Preconception folate requirement

400 mcg

4

When does organogenesis and cell differentiation occur?

GD20 - GD56

5

What is spina bifida?

failure to zipper the neural tube

6

Why is folic acid required?

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

7

FDA reproductive toxicity tests must be in:

rabbits + rats/mice at 3 doses

8

Cat A

adequate controlled studies in pregnant women
-- safe, no increased risk for fetal abnormalities

9

Cat B

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

10

Cat C

ADRs in animal studies but no human studies, or
no studies in either

11

Cat D

controlled or simple observational human studies show fetal harm

12

Cat C

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

13

Cat C drugs

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

14

Cat D drugs

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

15

Cat B drugs

APAP

16

Problem with old pregnancy categories

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

17

What are the new pregnancy categorization?

3 sections of narrative form
-- Clinical Management Statement
-- Summary Risk Assessment
-- Discussion of Animal and Human Data

18

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

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

19

What is the new rule on risk statements?

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

in that order

20

What are the old labeling categoreis

pregnancy
labor and delivery
nursing mothers

21

What are the new labeling categories?

pregnancy
lactation
females and males of reproductive potential

22

Why is nicotine patch in Cat D?

associated with premature labor and delivery

23

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

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

24

Describe nicotine's distribution affecting the baby.

Readily crosses placenta
accumulates in amniotic fluid

25

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

1) rat/mice have post-natal CNS growth spurt
2) human brain develops into teens

26

How does birth weight correlate with CNS dysfunction?

it does not

27

What are the effects of nicotine exposure in utero?

out of sequence ACh-regulated events
-- block apoptosis
-- increases neurotrophin synthesis
-- upregulates a4
-- increases nAChR density

28

What does ACh regulate in utero?

neuron growth
neuron migration
synaptogenesis

29

When does ACh release begin in utero?

GD18

30

What are smoke exposure's effects on the neonate?

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

31

What are smoke exposure's effects on teens?

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

32

What is the most preventable cause of mental retardation?

Alcohol, the only rec drug to be a teratogen

33

What are the facial features of FASD?

short palpebral fissures
indistinct philtrum
thin upper lip

34

How is FASD diagnosed?

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