Pregnancy and Lactation

• Identify commonly used meds to avoid in pregnancy

  ACE inhibitors, ARBs, Direct Renin inhibitors, Statins, Tetracyclines, NSAIDs
• Brief exposure and teratogenic outcomes

  Women can be reassured if they’ve had brief exposure to certain medications during pregnancy, that they would not be considered teratogenic, not intended to encourage use
• Pregnancy and Lactation Labeling Final Rule (PLLR)

  • Purpose of new PLLR is to assist healthcare providers in assessing benefit versus risk
  • Pregnancy: includes labor and delivery
  • Lactation: includes nursing mothers
  • Females and Males of reproductive potential
• Define pregnancy exposure registries

  • Collect health information from women who take medicines and vaccines when they are pregnant and breastfeeding
  • Information is also collected on newborn baby
  • Information collected is compared with women who have not taken medicine during pregnancy
• Previous risk categories in pregnancy

  • A: Adequate, well controlled studies reveal NO RISK to fetus during first trimester
  • B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
  • C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
• Previous risk categories in pregnancy

  • D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
  • X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.