FDA perspective on and response to the risk of hepatitis A from blood products.
The clinical and laboratory data available on hepatitis A virus infections reported in Europe were reviewed by the Blood Products Advisory Committee of the Food and Drug Administration. The panel's consensus was that the clotting factor concentrates currently available in the United States are safe with respect to viral diseases, hepatitis A transmissions do not appear to be a significant health problem, and there is a paucity of epidemiologic data on hepatitis A in patients with hemophilia in the United States.
Fricke
W
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Food and Drug Administration, Bethesda, Md.
D001779:Blood Coagulation Factors / Q000009:adverse effects* / Q000302:isolation & purification; D016208:Databases, Factual; D003902:Detergents; D004196:Disease Outbreaks; D004340:Drug Contamination; D005060:Europe / Q000453:epidemiology; D006506:Hepatitis A / Q000453:epidemiology / Q000517:prevention & control / Q000635:transmission*; D006801:Humans; D010322:Parvoviridae Infections / Q000453:epidemiology / Q000517:prevention & control / Q000635:transmission; D012306:Risk; D012449:Safety; D012997:Solvents; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
D001779:Blood Coagulation Factors; D003902:Detergents; D012997:Solvents