FDA pregnancy risk classification system removed
As of June 30, 2015, the US FDA removed the well known A, B, C, D, and X pregnancy risk classification system for prescription drugs and biological products [FDA HHS. Fed Regist. 2014;79(233):72063] The old classification system did not always consistently communicate differences in fetal risk and failed to take into account the risk of the untreated condition, resulting in a tendency to oversimplify risk assessment of drug safety in perinatal women. The new “Pregnancy and Lactation Labeling Rule” (PLLR) requires the elimination of the letter categories from labeling and may impact over 6 million women taking prescription medication during gestation.
The PLLR includes three subsections, Pregnancy, Lactation, and Females and Males of Reproductive Potential. The PLLR mandates that labeling include data on dosing and potential fetal risks. Although previously not required, manufacturers must now provide information about pregnancy exposure registries that collect and maintain data on pregnant women when available.
The lactation subsection includes information about the amount of drug in breast milk and potential effects on breastfed infants. A new subsection includes information about pregnancy testing, contraception, and infertility.
The PLLR does not affect over-the-counter medicines, and medications approved after 30 June 2001 will be phased in gradually. With the new format and additional data, health-care professionals are able to better inform and counsel patients requiring medication during pregnancy or while breastfeeding, while allowing greater numbers of women to participate in registries designed to collect data on a patient population that is often under-represented in research studies.
The opinions herein are those of the author and do not necessarily represent those of the Department of the Navy, the Department of Defense, or the United States government.