By: Dr. Geoffrey Modest
The FDA just came out with changes in labeling information regarding pregnancy and lactation on prescription drugs and biological products, replacing the old system of letter categories (A, B, C, D and X). These changes will go into effect June 30, 2015 (see FDA release).
In brief:
–The “pregnancy” subsection will provide information on the use of the drug in pregnant women (eg, dosing and potential risks to the fetus), and whether there is a registry collecting data on how pregnant women are affected by the drug.
–The “lactation” subsection will comment on the amount of drug in breast milk and potential effects on the breastfed child
–The “females and males of reproductive potential” subsection will include comments on the drug’s effect on pregnancy testing, contraception, and infertility
–Both the “pregnancy” and “lactation” subsections will include 3 subheadings: “risk summary”, “clinical considerations” and “data”, with information on human and animal data and specific adverse reactions of concern for pregnant of lactating females