FDA updates Pregnancy and Lactation Labeling

6/23/15

Today I did research related to the updated pregnancy and lactation labeling that will take effect beginning 6/30/15. It separates pregnancy and lactation into 3 new subheadings: 8.1 Pregnancy (includes Labor and Delivery), 8.2 Lactation, and 8.3 Females and Males of Reproductive Potential.  It will apply to all new drugs approved after June 30^th. Drugs that were approved after June 29, 2001 will have 3 years to comply with the new labeling. Those that were approved before June 29, 2001 do not need to adopt the new labeling requirements, but they will need to remove the current letter labeling. The new FDA labeling provides more detailed information about each risk rather than just stratifying the risk into a letter category. Finally, it will provide more guidance about clinical decision making to help clinicians make decisions about what medication to use. In addition, it will help quantify what exactly needs to be done when females or males use the medication related to pregnancy tests or appropriate contraception.