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FDA Approves Octaplas for Clotting Disorders

Plasma product has been in use in Europe for more than a decade (Jan. 17)

The FDA has approved Octaplas (Octapharma), 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 suitable U.S. donors who have been screened and tested for diseases transmitted by blood.

Like fresh-frozen plasma, Octaplas should be matched to the recipient’s blood group to help avoid transfusion reactions. An additional benefit of Octaplas is that each lot is tested for the composition of key clotting factors and is released for use only 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 2006. All generations of the product have had similar manufacturing processes and comparable ingredients and properties. More than 2 million patients have been treated with more than 7 million doses of Octaplas outside the U.S.

The licensing of Octaplas was primarily based on clinical studies conducted in patients with liver disease, liver transplant, heart surgery, and thrombotic thrombocytopenic purpura (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, rashes, headache, and tingling sensations.

Source: FDA; January 17, 2013.

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