The 2015 US Food and Drug Administration Pregnancy and Lactation Labeling Rule

Area of Science:

• Pharmacology
• Obstetrics & Gynecology
• Drug Safety Regulation

Background:

• The previous ABCDX system for pregnancy drug risk categorization was discontinued by the FDA in 2015.
• This system provided limited information on drug safety during pregnancy.

Purpose of the Study:

• To review the key components of the FDA's Pregnancy and Lactation Labeling Rule (PLLR).
• To discuss the clinical implications of the PLLR for healthcare providers.
• To provide resources for clinicians prescribing medications to women of reproductive age.

Main Methods:

• Review of FDA documentation and regulatory guidelines.
• Analysis of the structure and content requirements of the PLLR.
• Synthesis of clinical implications based on the new labeling requirements.

Main Results:

• The PLLR replaces the ABCDX categories with a narrative format.
• The new rule includes three main sections: pregnancy (including labor and birth), lactation, and reproductive potential in females and males.
• The PLLR mandates detailed risk information, clinical considerations, and background data for drugs.

Conclusions:

• The PLLR offers a more comprehensive approach to communicating drug risks during pregnancy and lactation.
• Healthcare providers need to understand the PLLR to effectively counsel patients on medication use.
• Resources are available to support clinicians in applying the PLLR to patient care.