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Experts Press to Include Pregnant People in Drug Trials After Tylenol–Autism Claims

Specialists say decades of automatic exclusion have left patients without clear guidance.

Overview

  • The Trump administration’s recent statement linking acetaminophen use in pregnancy to autism reignited debate over how medications are studied during pregnancy and breastfeeding.
  • Maternal health providers argue that routine exclusion from trials has created a research gap that forces decisions based on theoretical risks instead of solid evidence.
  • Clinicians call for a shift from blanket bans to a model of protection through research, using informed consent to let pregnant patients decide whether to enroll.
  • Experts note the legacy of thalidomide shaped extreme caution, even though the drug had not been tested in pregnant women before it was prescribed for nausea.
  • Including pregnant participants in appropriately designed studies could clarify which treatments are harmful, which are safe, and which are necessary for maternal and fetal health.