FDA Plans Immune Globulin Adverse Reactions Workshop

FDA has announced a 3/30 workshop entitled “Immune Globulin (IG) Hypersensitivity Reactions: Root Causes and Mitigation” that is intended to address “excessive numbers” of hypersensitivity reactions for specific product lots. While hypersensitivity is listed as a possible reaction to IG products, increased reports have led to voluntary market withdrawals of IG product lots and adversely affected a proportion of patient recipients, an FDA notice says. “Resulting withdrawals of product lots and quarantine of manufacturing intermediates can adversely affect IG supply,” it says.

FDA says that the purpose of the workshop is to gain insight and to identify measures to prevent hypersensitivity reactions associated with specific IG lots. It says scientific experts will discuss:

• the most likely root causes;
• potential recipient risk factors; and
• developing in vitro methods to identify plasma units or products that mediate lot-specific hypersensitivity.