2013 Safety and Availability Communications
This webpage was developed to provide the public with important information about the safety and availability of biological products.
FDA Safety Communication: New boxed warning for thrombosis related to human immune globulin products
Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot 4030026 Through October 31, 2014
Dosing Decrease to 1.0 mL/kg (50 mg/kg) and Expiration Date Extension for Botulism Immune Globulin Intravenous (Human) (BIG-IV) Lot 5 to March 02, 2015.
FDA Safety Communication: Boxed Warning on increased mortality and severe renal injury, and additional warning on risk of bleeding, for use of hydroxyethyl starch solutions in some settings
FDA Releases Final Study Results of a Mini-Sentinel Postlicensure Observational Study of Rotavirus Vaccines and Intussusception
Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin)
FDA Safety Communication: Safety risk from reproductive tissue at the New York Fertility Institute of New York, New York
Information for Blood Establishments: DISCONTINUATION of CHIRON® RIBA® HCV 3.0 SIA (RIBA)