Pharm of and during pregnancy Flashcards
Paroxetine- FDA risk category, trimester, and specific adverse effects
D
3rd trimester
neonatal abstinence syndrome, peristent pulmonary htn of the newborn
lisinopril- FDA risk category, trimester, and specific adverse effects
D
Trimesters: All, especially 2nd and 3rd
Renal damage, hypocalvaria
Warfarin - FDA risk category, trimester, and specific adverse effects
D (for women with mech heart valves, but X for other pregnant populations)
1st, 2nd, 3rd
Hypoplastic nasal bridge, chondrodysplasia
CNS malformations
Risk of bleeding; discontinue use 1 month before delivery
FDA Teratogenic Risk Categories: A
Controlled studies show no risk. Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of a risk in late trimesters) and the possibility of fetal harm appears remote.
FDA Teratogenic Risk Categories: B
No evidence of risk in humans. Either animal-reproduction studies have not demonstrated a fetal risk, but there are no controlled studies in pregnant women, or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters).
FDA Teratogenic Risk Categories: C
Risk cannot be ruled out. Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
FDA Teratogenic Risk Categories: D
Positive evidence of risk. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
FDA Teratogenic Risk Categories: X
Contraindicated in pregnancy. Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
New FDA Labeling System
Implemented on 6/30/2015
Removed the letter categories (A, B, C, D, and X)
Requires narrative statements that summarize the evidence-based information available regarding fetal risk and safety
Applies to new drug applications immediately
Gradually phased in for drugs approved between 2001-2015
Management of Depression in Pregnant Patients
Consider risks of untreated depression versus risks of pharmacotherapy
- Presence/absence of current symptoms
- Current pharmacotherapy regimen
- Previous response to psychotherapy
Most antidepressants are category C or D
Single agent at higher dose is favorable to multiple agents
Avoid antiepileptic mood stabilizers (carbamazepine, valproic acid)
You advise the patient to stop taking lisinopril. Which agent is the most appropriate replacement monotherapy for outpatient management of the patient’s chronic hypertension?
Hydralazine Hydrochlorothiazide Labetalol Losartan Magnesium sulfate
labetalol
Management of Hypertension in Pregnancy: Oral agents for mild-to-moderate HTN
1st line: labetalol, nifedipine, or methyldopa
2nd line: thiazide diuretics
Management of Hypertension in Pregnancy: Agents for MGMT of acute severe HTN
Labetalol (IV), nifedipine (oral), hydralazine (IV or IM)
Sodium nitroprusside (IV) can be used for refractory HTN
Beware of possibility for fetal cyanide poisoning
Management of Hypertension in Pregnancy: For women with preeclampsia
Magnesium sulfate to reduce risk of eclampsia (seizures)
Management of Hypertension in Pregnancy: Antihypertensives to avoid during pregnancy
ACE inhibitors
ARBs (Angiotensin Receptor Blockers)
Direct renin inhibitors
