Pregnancy and Lactation Labeling

The U.S. Food and Drug Administration (FDA) is proposing major revisions to prescription drug labeling to provide more complete information about the effects of medicines used during pregnancy and breast-feeding.  The proposed changes to physician labeling would give healthcare providers better information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age.

FDA proposes that the pregnancy and lactation subsections of labeling include a risk summary, which summarizes the risks of the medicine to the developing baby (fetus) or breast-feeding infant, and a discussion of the data supporting that summary.  The labeling would also include relevant clinical information useful for counseling pregnant or lactating women about medications, and prescribing and managing use of those medications.

The proposal would eliminate the current pregnancy categories A, B, C, D, and X.  The “Labor and Delivery” subsection would be eliminated because information on labor and delivery would be included in the “Pregnancy” subsection.  The proposed rule is intended to create a consistent format for providing information about the risks and benefits of medicine use during pregnancy and lactation.  In doing so, the proposed rule would enhance well-informed decision making by healthcare practitioners and women of childbearing age.

• Proposed Rule This link goes to Regulations.gov; to see the proposed rule, click on either the HTML or PDF icon under the "Views" column. This link also provides information on how to submit comments.
• Summary of Proposed Rule on Pregnancy and Lactation Labeling
• FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding  
• Consumer Article: Pregnant Women to Benefit from Better Information
• Questions and Answers on the Pregnancy and Lactation Labeling Rule   
• Transcript of FDA Media Briefing on Pregnancy and Lactation Labeling Proposal (PDF - 72KB)
• Fictitious Example – Pregnancy  
• Fictitious Example – Lactation 
• Guidance for Industry:
  • Establishing Pregnancy Exposure Registries (PDF - 268KB) (final 8/2002) 
  • Pharmacokinetics During Pregnancy and Lactation (PDF - 324KB) (draft 10/2004)
  • Clinical Lactation Studies (PDF - 363KB) (draft 2/2005)
  • Integration of Study Results to Assess Concerns about Human Reproductive and Developmental Toxicities (PDF - 142KB) (draft 10/2001)
  • Evaluating the Risks of Drug Exposure in Human Pregnancies (PDF - 3MB) (final 4/2005)
  • Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications