Medication safety in pregnancy

Medication safety in pregnancy

Medication safety in pregnancy

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FDA Risk Categories - Alphabet Soup Shake-up

  • Old System (Pre-2015): Letter categories (A, B, C, D, X) ranked risk from controlled human studies to clear contraindication.

    • A: No risk (human studies).
    • B: No evidence of risk (animal studies).
    • C: Risk cannot be ruled out.
    • D: Positive evidence of risk.
    • X: Contraindicated.
  • New System (PLLR - 2015): Pregnancy and Lactation Labeling Rule.

    • Abolished letter categories for a narrative approach.
    • Requires detailed subsections: Pregnancy, Lactation, and Females & Males of Reproductive Potential.

FDA Pregnancy and Lactation Labeling Rule Comparison

⭐ The PLLR provides a risk summary but requires clinical judgment, moving away from the perceived (and often misinterpreted) simplicity of the A/B/C/D/X system.

Common Teratogens - The Pregnancy Poison List

Teratogenic Exposure Outcomes by Gestational Stage

  • General Principle: Avoid all non-essential medications, especially during the first trimester (organogenesis).
Drug/SubstanceCategory & Effect
AlcoholFetal Alcohol Syndrome (FAS): smooth philtrum, thin upper lip, microcephaly, cognitive deficits.
ACE Inhibitors/ARBsRenal dysgenesis, oligohydramnios, skull ossification defects.
IsotretinoinExtremely teratogenic. Craniofacial, cardiac, and CNS defects. Requires iPLEDGE program.
PhenytoinFetal hydantoin syndrome: craniofacial abnormalities, hypoplastic nails, developmental delay.
ValproateHigh risk of neural tube defects (e.g., spina bifida). Dose-dependent effect.
LithiumEbstein's anomaly (atrialization of right ventricle).
WarfarinBone and cartilage defects (stippled epiphyses), nasal hypoplasia. Use heparin/LMWH instead.
TetracyclinesDiscolored teeth, inhibited bone growth.
MethotrexateCNS and limb abnormalities.
ThalidomidePhocomelia (limb reduction defects).

📌 Mnemonic: "Teratomas"

  • Thalidomide
  • Epilepsy drugs (Phenytoin, Valproate)
  • Retinoid (Isotretinoin)
  • ACE inhibitors/ARBs
  • Third element (Lithium)
  • Oral contraceptives (Androgens)
  • Methotrexate
  • Alcohol
  • Smoking/Warfarin

Safe Swaps - Green-Light Alternatives

ConditionAvoid (Teratogenic)Safe Alternative(s)
HypertensionACE Inhibitors, ARBsLabetalol, Nifedipine, Hydralazine, Methyldopa
AnticoagulationWarfarinLMWH (e.g., Enoxaparin), Unfractionated Heparin
DiabetesMost Oral AgentsInsulin, Metformin, Glyburide
EpilepsyValproate, PhenytoinLevetiracetam, Lamotrigine (requires ↑ folate)
Pain/HeadacheNSAIDs (esp. 3rd tri)Acetaminophen (Paracetamol)
DepressionParoxetineSertraline (Zoloft), Citalopram

High‑Yield Points - ⚡ Biggest Takeaways

  • ACE inhibitors & ARBs are contraindicated, causing fetal renal damage and oligohydramnios.
  • Avoid warfarin (causes nasal hypoplasia); use heparin/LMWH for anticoagulation.
  • Valproate and carbamazepine are strongly associated with neural tube defects.
  • Isotretinoin is a potent teratogen requiring two forms of contraception.
  • Avoid NSAIDs in the 3rd trimester to prevent premature ductus arteriosus closure.
  • Treat maternal hypertension with labetalol, nifedipine, or methyldopa.

Practice Questions: Medication safety in pregnancy

Test your understanding with these related questions

A 25-year-old G1P0 woman at an estimated gestational age of 9 weeks presents for her first prenatal visit following a positive home pregnancy test. She says she missed 2 periods but assumed it was due to stress at work. She has decided to continue with the pregnancy. Her past medical history is significant for migraine headaches, seizures, and asthma. She takes multiple medications for her condition. Physical examination is unremarkable. An ultrasound confirms a 9-week-old intrauterine pregnancy. Which of the following medications poses the greatest risk to the fetus?

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Flashcards: Medication safety in pregnancy

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_____ is the presence of too little amniotic fluid and may be associated with placental insufficiency, bilateral renal agenesis, and posterior urethral valves (inability to excrete urine)

TAP TO REVEAL ANSWER

_____ is the presence of too little amniotic fluid and may be associated with placental insufficiency, bilateral renal agenesis, and posterior urethral valves (inability to excrete urine)

Oligohydramniosis

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