Meds in Pregnancy

Question 1

1979-2015 FDA pregnancy categories established A-D, X, and N…what does each mean?

Answer 1

A= no risk to fetus in any trimester

B = no risk shown in animal studies, but no studies in pregnant women

C = animal studies have shown AEs, but no studies in humans, potential benefits may warrant use despite risks

D = positive evidence of human fetal risk, but can use if benefits outweighs the risk

X = don’t use unless absolutely necessary

N = not classified

Question 2

New FDA labeling uses three subsections for risk: pregnancy, lactation, females/males reproductive potential…explain each

Answer 2

Pregnancy: use of drug in pregnant women (dosing, potential risk to fetus, registry about risk summary, clinical considerations, and data)

Lactation: risk summary, clinical considerations, and data

F/M Repro Potential: pregnancy testing, contraception, infertility related to drug

Question 3

Decreased gastric emptying/SI motility, increase in gastric pH, N/V, inhalation drugs, IM delivery

Answer 3

Pharmacokinetic changes in absorption (study)

Question 4

Total body water increased up to 8L, albumin concentration, body fat increased by approx 4kg

Answer 4

Pharmacokinetic changes in distribution (study)

Question 5

P450 system can be induced or inhibited by estrogen and progesterone (higher or lower rate of….)

Answer 5

Metabolism (P450 system)

Question 6

Renal blood flow increased by 60-80%, GFR increased by 50% (meaning increased…)

Answer 6

Elimination

Question 7

Dependent on placental blood flow, some don’t cross placenta, large molecular weight don’t cross, metabolism in immature fetal liver/placenta?

Answer 7

Pharmacokinetic changes in fetal-placental drug transfer

Question 8

Due to fetal circulation bypassing fetal liver to heart and brain, elimination low through maternal compartment, acidic fetal plasma favors movement of lipophilic drugs form mom to fetus?

Answer 8

Pharmacokinetic changes in fetal drug accumulation

Question 9

Non-pharm, ginger, doxylamine, stopping use of diphenhydramine/meclizine, add metoclopromide, switch antihistamines to promethazine or procholperazine, add ondansetron or glucocorticoids

What are these for?

Answer 9

Nausea in pregnancy

Question 10

No known safety concerns, reduces nausea but not vomiting?

Answer 10

Ginger

Question 11

Improves mild-moderate nausea, but not vomiting, no teratogenic concerns, but can cause sensory neuropathy at high doses?

Answer 11

Pyridoxine (Vitamin B6)

Question 12

Combo of these tow used for nausea and vomiting, moderately effective, removed in 1983 due to teratogenic concerns but there’s scientific basis for this/show safe use in pregnancy?

Answer 12

Doxylamine and pyridoxine combo

Question 13

Used for persistent N/V, discontinue use of doxylamine prior to starting these

Answer 13

Meclizine and diphenhydramine

Some risk of cleft pallet malformation with Meclizine

Question 14

Dopamine antagonists for persistent N/V?

Answer 14

Metoclopromide (long term use could see tardive dyskinesia, dystonia)

Promethazine (sedation and dystonia, lowers seizure threshold)

Prochlorperazine (some case reports of malformations, not conclusive trials)

Question 15

Two serotonin antagonists for persistent N/V?

Answer 15

Ondansetron (controversial…two trials showed a bunch of risks)

Granisetron (no safety data in pregnancy)

Question 16

Used in short course for refractory N/V, avoid in 1st trimester due to cleft palate risk, exaggerated AEs in pregnancy?

Answer 16

Glucocorticoids

Promethazine and Metoclopramide are probably more efficacious

Question 17

What do we do for GE reflux in preg?

Answer 17

Smaller meals, less spicy, elevate bed, antacids, sucralfate, H2 antagonists, PPI

Question 18

Safe in pregnancy and lactation, can be constipating (aluminum and calcium) or diarrhea (magnesium)

Answer 18

Antacids

Question 19

Not well absorbed, likely safe, forms viscous paste-like gastric lining?

Answer 19

Sucralfate

Question 20

Ranitidine and cimetidine have the most safety data, excreted in breast milk?

Answer 20

H2As

Question 21

Likely safe in pregnancy, excreted in breast milk but destroyed by baby’s stomach?

Answer 21

PPIs: omeprazole, lansoprazole, pantoprazole have most data

Question 22

The one absolute NONO drug in pregnancy for reflux?

Answer 22

Bismuth Subsalicylate (pepto-bismol)

Question 23

Meds in pregnancy for constipation?

Answer 23

Fiber, docusate, mag hydroxide or lactulose or bisacodyl for refractory cases

Question 24

Not shown to be teratogenic in animals, but human studies are inconclusive, drug for diarrhea?

Answer 24

Loperamide

Question 25

Cannot use NSAIDs or ASA in preg for pain, so use what?

Answer 25

Acetaminophen, but there is possibly an ADHD risk

Question 26

Antihistamines preferred in preg?

Answer 26

1st: diphenhydramine and chlorpheniramine
2nd: fexofenadine, loratadine, cetirizine

Question 27

For cough suppressants, codeine, hydrocodone, dextromethorphan can cause withdrawal symptoms in baby with long-term use…one large trial correlated what with opioid use?

Answer 27

Congenital anomalies

Also don’t use Guaifenisin (inguinal hernias)

Question 28

For rhinorrhea, sneezing, throat pain, best to use what?

Answer 28

Clean water spray, cepacol

Decongestant: short term use of intranasal oxymetazoline may be beneficial, but not well studied

Question 29

For the Abx, look at the chart (slide 34) and know which ones to absolutely not use

Answer 29

Slide 34

Question 30

Three anti-fungal drugs that are absolutely NOs?

Answer 30

Butoconazole and Miconazole/Ticonazole

Question 31

Best anti-virals during pregnancy?

Answer 31

Valacyclovir (Valtrex) is considered safe

Question 32

In terms of topical creams/ointments, what two groups do we absolutely not use?

Answer 32

High-potency steroids and Tretinoin (Retinoid/Retin A)

Question 33

Begins 20th week after pregnancy (typically 3rd trimester) - pregnancy induced HTN presents with persistent headaches, blurred vision, ab pain, light sensitivity

Answer 33

Preeclampsia

Lifestyle changes work, for meds we use Methyldopa or Labetalol

Urgent/emergent: hydralazine, labetalol, nifedipine

Question 34

Very serious complication of preeclampsia characterized by one or more seizures during pregnancy…if untreated can kill…presents with seizures, swelling, sudden weight gain, coma, brain damage, death

Answer 34

Eclampsia, DOC is Magnesium Sulfate IV, IV fluids

Question 35

Gestational DM if left untreated = large birth weight, premature delivery, C-section, increased risk of death of fetus, how we treat?

Answer 35

Insulin…need specialized care though b/c it’s complicated (all are cat B except glaring and glulisine which are C)

Glyburide and Metformin are both cat B, but lack long-term safety data

Question 36

NTD risk increased with family history, certain anti-seizure meds, obesity, diabetes

How do we prevent?

Answer 36

400-1000mcg folic acid/day before

1000mcg folic acid/day during preg

Prior preg w/NTD: 4mg folic acid at least 1 month before peg and throughout 1st trimester

Question 37

Anemia (IDA, folate-deficiency anemia, Vit B12 deficiency anemia), how we treat?

Answer 37

Iron rich food, non-animal protein, recommended iron daily allowance for pregnancy is 27 mg/day

Supplements: ferrous fumarate, ferrous sulfate, ferrous gluconate

Question 38

Meds in lactation, don’t take right before breastfeeding

Answer 38

If med is not safe for infant, discontinue if possible, if short term pump and dump, if long term switch to formula