Potential health benefits 2008
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APPROVAL / USE / INDICATIONS
The U.S. Food and Drug Administration on October 10 2008 approved a new use for
the blood product Kogenate FS to reduce the frequency of bleeding episodes and
prevent joint damage in children with the most severe form of hemophilia.
Hemophilia A is a rare, hereditary, bleeding disorder in which a protein needed to
form blood clots, factor VIII, is missing or its level is reduced. The disorder affects
about 15,000 individuals in the United States, nearly all of whom are male.
When individuals with hemophilia are injured, they bleed longer than a person
without hemophilia. As a result, these individuals may experience serious bleeding
episodes, often in the joints and muscles. Repeated bleedings increase the chance
of joint damage.
Kogenate FS is a genetically engineered version of factor VIII. It was first licensed in
the United States in 1993 for use during surgery and to prevent or control other
In a clinical trial, 65 boys under 30 months of age with severe hemophilia A and
normal joints were observed for five years. The patients received either one daily
dose of the drug, or three doses at the time of a bleeding episode. Joint damage
during a bleeding episode was 6-fold lower, and the rate of bleeding 8-fold lower, in
those boys who received the drug on a daily basis compared to those who received
the drug only when a bleeding episode occurred. Most patients received the drug
intravenously through a catheter.
COMMON SIDE EFFECTS / SAFETY ISSUES / CONTRAINDICATION
The most common adverse events were infection at the catheter site and fever.
Kogenate FS is manufactured by Bayer Healthcare LLC, Tarrytown, N.Y.
 FDA News 2008