Pharmacotherapy

Updated review details antibiotic safety in pregnancy

March 21, 2025

Antibiotics are commonly prescribed to pregnant women to treat various infections, posing potential risks to both mother and fetus. This updated review provides a summary of the safety of antibiotics in pregnancy, focusing on newly approved antibiotics and additional evidence on previously reviewed antibiotics.

Key points:

• New antibiotics: Since 2014, 19 new antibiotics have been approved by the FDA, necessitating updated safety profiles for use in pregnancy. New antibiotics include plazomicin, ceftolozane, cefiderocol, and others.
• Antibiotic resistance: Antibiotic resistance is prevalent among pregnant women with active infections, leading to more complicated cases such as pyelonephritis.
• FDA Pregnancy and Lactation Labeling Rule (PLLR): The PLLR, finalized in 2015, requires updated narrative components in medication labels, including sections on pregnancy, lactation, and reproductive potential.
• Antibiotic stewardship: Stewarding antibiotics during pregnancy is crucial to protect the woman, fetus, and newborn, and to reduce the development of antibiotic resistance.
• Safety data: For newly approved antibiotics, safety data are often derived from animal studies, which may not always translate directly to human pregnancy outcomes.
• Specific antibiotic classes:
  Aminoglycosides: Generally avoided in pregnancy due to risks of nephrotoxicity and ototoxicity, except for short-term use with careful monitoring (excluding streptomycin).Beta-lactams: Considered safe, but caution is advised with certain drugs like ceftriaxone at term.Macrolides: Conflicting data on safety, with some studies showing increased risks of spontaneous abortion and birth defects.Fluoroquinolones and tetracyclines: Should be avoided due to potential teratogenic effects.

Source:

Nguyen J, et al; as part of the Southeastern Research Group Endeavor (SERGE‐45) research network. (2025, March 19). Pharmacotherapy. A review of antibiotic safety in pregnancy-2025 update. https://pubmed.ncbi.nlm.nih.gov/40105039/