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FDA Pregnancy Risk Information: An Update
In 2015 the FDA replaced the former pregnancy risk letter categories (see below) on prescription and biological drug labeling with new information to make them more meaningful to both patients and healthcare providers. The FDA received comments that the old five-letter system left patients and providers ill-informed and resulted in false assumptions about the actual meaning of the letters.
The new labeling system allows better patient-specific counseling and informed decision making for pregnant women seeking medication therapies. While the new labeling improves the old format, it still does not provide a definitive “yes” or “no” answer in most cases. Clinical interpretation is still required on a case-by-case basis.
The Pregnancy and Lactation Labeling Final Rule (PLLR) went into effect on June 30, 2015; however, the timelines for implementing this new information on drug labels (also known as the package insert) is variable.
Prescription drugs submitted for FDA approval after June 30, 2015 will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001 will be phased in gradually. Medications approved prior to June 29, 2001 are not subject to the PLLR rule; however, the pregnancy letter category must be removed by June 29, 2018. For generic drugs, if the labeling of a reference listed drug is updated as a result of the final rule, the abbreviated new drug application (ANDA) labeling must also be revised. Labeling for over-the-counter (OTC) medicines will not change, as OTC drug products are not affected by the new FDA pregnancy labeling.
The A, B, C, D and X risk categories, in use since 1979, are now replaced with narrative sections and subsections to include:
Pregnancy (includes Labor and Delivery):
- Pregnancy Exposure Registry
- Risk Summary
- Clinical Considerations
Lactation (includes Nursing Mothers)
- Risk Summary
- Clinical Considerations
Females and Males of Reproductive Potential
- Pregnancy Testing
The Pregnancy subsection will provide information about dosing and potential risks to the developing fetus and registry information that collects and maintains data on how pregnant women are affected when they use the drug or biological product. Information in drug labeling about the existence of any pregnancy registries has been previously recommended but not required until now. Contact information for the registries will also be included, and pregnant women are encouraged to enroll to help provide data on the effects of drug use or biologics in pregnancy.
If information for the subsections of Pregnancy Exposure Registry, Clinical Considerations, and Data is not available, these subsections will be excluded. The Risk Summary subheadings are always required, even if no data is available.
The Lactation subsection will replace the “Nursing Mothers” subsection of the old label. Information will include drugs that should not be used during breastfeeding, known human or animal data regarding active metabolites in milk, as well as clinical effects on the infant. Other information may include pharmacokinetic data like metabolism or excretion, a risk and benefit section, as well as timing of breastfeeding to minimize infant exposure.
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