Wednesday, June 24, 2009

FDA Approves Treatment for Rare Genetic Defect

RiaSTAP, a new drug for treatment for patients living with congenital fibrinogen deficiency, a condition that affects blood coagulation, has reportedly gained FDA approval.
According to FDA officials, the condition, which affects only 150-300 people in the U.S., can lead to potentially life-threatening bleeding without treatment and is usually diagnosed at birth.
An intravenous fibrinogen concentrate made from the plasma of healthy human blood donors, RiaSTAP is indicated for patients who have no fibrinogen or low levels of the substance. The FDA warns that RiaSTAP is not indicated for patients with dysfibrinogenemic (those who may have normal fibrinogen levels but defective fibrinogen function) as these individuals are at risk for both bleeding and clotting complications.
Fever and headache were the most common adverse reactions to the drug, the FDA reported.