Coming Soon: New Pregnancy and Lactation Drug Labeling

January 13, 2015

A final rule issued by FDA will change the way drug manufacturers provide information for the "Pregnancy" and "Nursing Mothers" subsections.

A final rule issued by FDA on December 3, 2014, will change the way drug manufacturers provide information for the “Pregnancy” and "Nursing Mothers" subsections.

The labeling changes allow for a more consistent method for manufacturers to provide information on the risks associated with the use of medications during pregnancy and lactation. In addition, they provide for more detailed information on the risks associated with medication for females and males of reproductive potential.

Here is a quick overview:

The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription medication and biological product labeling.

The decision to remove the pregnancy categories was based on the realization that they were heavily used by health care providers when making prescribing decisions, but often misinterpreted and misused. The selection of medications was being based solely on the category rather than understanding the data that led to its assignment.

Now, the prescribing information will include more detailed information, including risk summary and supported data, on the use of medication during pregnancy and lactation. The data can come from various sources, such as published studies and pregnancy exposure registries.

The prescribing information will now incorporate relevant facts, which may include:

  • Information regarding disease-associated maternal and fetal risks
  • Dose adjustments during pregnancy and the postpartum period
  • Possible adverse drug reactions for both the mother and fetus
  • Effect of the medication on labor or delivery
  • Detailed information on risk versus benefit
  • Information on the presence of the medication in human milk and effects of the medication on the breastfed child milk production

In addition, the information that was once found in the “Labor and Delivery” subsection will now be included in the “Pregnancy” subsection.

The prescribing information will also now include relevant risk and benefit information on prescription medication and/or biological product use in females and males of reproductive potential. This section will include information about pregnancy testing, contraception, and infertility.

These revisions should assist health care providers in making informed medication selections and counseling these specific populations on the associated risks of medications.

This rule will become effective on June 30, 2015, and apply to prescription medications and biological products. According to the FDA, such products submitted after June 30, 2015, will need to apply the new format. For prescription medications approved on or after June 30, 2001, manufacturers will need to remove the pregnancy category within 3 years of the effective date of the final rule.