The pregnancy risks associated with prescription drugs and biologic products will soon be more clearly delineated on product labels with a new system that requires three subsections — “Pregnancy,” “Lactation,” and “Females and Males of Reproductive Potential” — rather than the current letter-based system (A, B, C, D, and X), the FDA announced on Wednesday.
The “Pregnancy” section will discuss dosing considerations, possible risks to the fetus, and other information relevant to prenatal use. It will also note whether there’s a registry that maintains data on how pregnant women are affected by the product.
The “Lactation” section will note the amount of drug that may be in breast milk and the potential effects on the child, among other considerations.
The “Females and Males of Reproductive Potential” section will include information about pregnancy testing, contraception, and infertility as it relates to the product.
The new system will go into effect at the end of June 2015.
FDA news release