Safety issues affecting hemophilia products.

Clotting factor concentrates (CFCs) have evolved substantially toward both safety from pathogens and overall final purity of the products. The array of product types for both factor VIII and factor IX CFCs ranges from so-called intermediate purity (containing multiple plasma proteins), very high purity (containing chiefly the respective purified clotting protein plus an albumin stabilizer), and recombinant CFCs (with or without albumin stabilizers). Each is discussed in the context of theoretic safety, other possible effects on the host (eg, immunogenicity), and the niche that each occupies in the armamentarium for hemophilia therapy. The difficulty in applying a cost-efficacy model for making societal choices about appropriate product selection is discussed in the context of potential or emerging threats to CFC safety (e.g., variant Creutzfeldt-Jakob disease).