New vs Old FDA Pregnancy/Lactation Labeling

If you are taking a medication approved by the FDA after June 2015, you might notice that the labeling insert around pregnancy and lactation has changed. In response to problems with the old labeling system, the FDA has started a new labeling system around pregnancy and lactation. All medications approved after June 2015 have the new labeling, medications approved between 2001-2015 will have until 2020 to make revisions, and medications approved prior to 2001 are not required to have revisions. Here is a summary of the differences:

Old FDA Labeling

ORGANIZATION OF SECTIONS

  1. Pregnancy
  2. Labor and delivery
  3. Nursing mothers

HOW PREGNANCY RISK INFORMATION IS IMPARTED

  1. Categories A, B, C, D, X
  2. Narrative with subsections:
    1. Teratogenic effects
    2. Non-teratogenic effects

HOW LACTATION RISK INFORMATION IS IMPARTED

  1. Narrative providing animal or human data

HOW REPRODUCTIVE INFORMATION IS IMPARTED

  1. Was not addressed

New FDA Labeling

ORGANIZATION OF SECTIONS

  1. Pregnancy (included labor and delivery)
  2. Lactation
  3. Females and males of reproductive potential

HOW PREGNANCY RISK INFORMATION IS IMPARTED

  1. No categories
  2. Narrative with subsections:
    1. Pregnancy exposure registry
    2. Risk summary
    3. Clinical considerations
    4. Data

HOW LACTATION RISK INFORMATION IS IMPARTED

  1. Narrative with subsections:
    1. Risk summary
    2. Clinical considerations

HOW REPRODUCTIVE INFORMATION IS IMPARTED

  1. If applicable, narrative describing if pregnancy testing or contraception required and effects on fertility.

To learn more about the differences in FDA labeling or to schedule an appointment, contact our offie today.

Live Mentally Healthy,
Dr. Jennie Byrne

Author
Dr. Jennie Byrne, M.D., PhD.

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