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FDA NEWS RELEASE

 
For Immediate Release: Jan. 17, 2013
Media Inquiries: Rita Chappelle, 301-796-4672, rita.chappelle@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA, OCOD@fda.hhs.gov
 

FDA approves Octaplas to treat patients with blood clotting disorders

 
The U.S. Food and Drug Administration today approved Octaplas, a pooled plasma (human) blood product for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficient levels. Clotting protein deficiencies can cause excessive bleeding or excessive clotting.
 
Octaplas is a sterile, frozen solution of pooled human plasma from several donors that has been treated with a solvent detergent process. This process kills certain viruses and thereby minimizes the risk of serious virus transmission. The plasma used to manufacture Octaplas is collected from U.S. donors who have been screened and tested for diseases transmitted by blood, and determined to be suitable donors.
 
“For patients suffering with clotting disorders, this product provides a viable alternative to single-donor Fresh-Frozen Plasma and provides a reduced risk of certain viral transmissions,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.
 
Like Fresh Frozen Plasma, Octaplas should be matched to the recipient’s blood group to help avoid transfusion reactions. An additional benefit to Octaplas is that each lot is tested for composition of key clotting factors and is only released if the levels are within acceptable ranges.
 
Octaplas has been used extensively in Europe and other countries. A previous generation of Octaplas was first marketed in 1992, and the current version has been marketed since 2009. All generations of the product have had similar manufacturing processes and comparable ingredients and properties. In total, more than 2 million patients have been treated with over 7 million doses of Octaplas outside of the United States.
 
The licensing of Octaplas was primarily based on clinical studies conducted in patients with liver disease, liver transplant, heart surgery and TTP. Additional data supporting the safe use of Octaplas for the U.S. market came from prior use of the products in Europe and other approved markets. Use of the product in Europe was not associated with transfusion-related acute lung injury, an uncommon but serious risk of transfusion with single units of plasma.
 
The most common adverse reactions observed in clinical studies included shortness of breath, dizziness, chest discomfort, skin itchiness and rashes, headache and tingling sensations.
 
The product is manufactured by Octapharma, Vienna, Austria.
 
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
 
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