Summaries of safety labeling changes approved by FDA—Boxed warnings highlights July–September 2024.

The article presents an update on changes to the safety labeling of drugs and therapeutic biologicals approved by the U.S. Food and Drug Administration from July to September 2024. A classwide boxed warning about serious hypersensitivity reactions was added to the labeling of several enzyme replacement therapies, such as Brineura and Cerezyme. Other products with new or revised boxed warnings include Copiktra, Estrasorb and Filspari.