Medications in Pregnancy: What Pharmacy Technicians Must Know

Drug Safety in Pregnancy

Many medications pose risks during pregnancy, and pharmacy technicians should be aware of common contraindications and counseling points. While clinical decisions rest with the pharmacist and prescriber, recognizing red flags during prescription processing can prevent serious harm.

The Old FDA Category System (A, B, C, D, X)

Although replaced in 2015, the old category system is still widely referenced and may appear on the PTCE:

Category A - Adequate studies show no risk to fetus (e.g., prenatal vitamins)
Category B - Animal studies show no risk, but no adequate human studies (e.g., metformin, amoxicillin)
Category C - Animal studies show adverse effects; use only if benefit justifies risk (e.g., fluconazole at high doses)
Category D - Positive evidence of human fetal risk, but benefits may warrant use (e.g., phenytoin)
Category X - Contraindicated in pregnancy; fetal risk clearly outweighs any benefit (e.g., isotretinoin, methotrexate, warfarin, statins)

The Pregnancy and Lactation Labeling Rule (PLLR)

Since 2015, the FDA requires new drug labels to include detailed narrative summaries under three subsections: Pregnancy, Lactation, and Females and Males of Reproductive Potential. This provides more nuanced information than the old letter categories.

Commonly Contraindicated Drugs

Isotretinoin (Accutane) - Severe birth defects; requires iPLEDGE program enrollment
Methotrexate - Abortifacient and teratogenic
Warfarin - Crosses the placenta; causes fetal warfarin syndrome
Statins - Cholesterol needed for fetal development
ACE inhibitors and ARBs - Renal damage in second and third trimesters
Tetracyclines and fluoroquinolones - Tooth discoloration and cartilage damage
Valproic acid - Neural tube defects

The Technician's Role

If a patient's profile indicates pregnancy and a contraindicated medication is prescribed, alert the pharmacist immediately. Some pharmacy systems flag these automatically, but manual awareness remains important.

Pregnancy-related drug safety is a patient safety topic that appears on the PTCE. Know the Category X drugs by memory.