FDA announces labelling changes for pregnancy and lactation information

3 Sep 2015 - 10:30

Prescription drugs were previously assigned pregnancy categories A, B, C, D and X, which essentially over-simplified the issue. These categories will now be replaced with three detailed sub-sections that describe risks in a real world context.

The Pregnancy subsection will contain a risk summary, clinical considerations and data, which will provide information such as dosing, possible foetal risks and whether a pregnancy registry exists.

The Lactation subsection will contain information such as how much of the drug is excreted in breast milk and expected effects on the infant.

The Females and Males of Reproductive Potential subsection will cover how the drug relates to pregnancy testing, contraception and infertility.

The new format should enable prescribers and patients to make an informed decision based on benefit vs risk. Newly approved drugs and biologicals will have to use this format with immediate effect whereas the labelling content of previously approved products will be phased in over a period of time.