The complaint from Public Citizen referenced in this docket requests removal of hydroxyethyl starch (HES) from the U.S. market. America’s Blood Centers, the American Red Cross, AABB and the American Society for Apheresis oppose this. These solutions met the extant regulatory requirements for approval when originally submitted, but the extensive literature on their lack of efficacy for resuscitation indications, and their association with adverse clinical outcomes resulted in “black box” warnings in the prescribing information. This makes the agency’s continuing review of their use in those indications appropriate. However, the broad case made for removal of the product from the market ignores, and in fact does not even recognize, other uses for HES, where available data do not suggest problems like those seen associated with resuscitation (see accompanying references).
