FDA approves Octaplas for blood-clotting disorders

FDA: Octaplas Approved for Blood-Clotting Disorders
FDA: Octaplas Approved for Blood-Clotting Disorders

HealthDay News -- The FDA has approved Octaplas to augment insufficient clotting proteins that could otherwise lead to excessive bleeding or excessive clotting.

The product is a sterile, frozen solution made from human plasma. A "solvent detergent process" is applied to minimize the possibility of serious viral transmission, according to the agency.

“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,” Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research said in a press release.
 
Like fresh-frozen plasma, Octaplas should be matched to the recipient's blood type to help avoid transfusion reactions. Each lot is measured for the required presence of clotting factors before the lot is approved for use, the FDA said.

The current version has been used in Europe and elsewhere since 2006, and a prior formulation was first used in 1992. In all, more than two million people have been treated with more than seven million doses outside the United States, the agency said.

Clinical trials have also been conducted in people with liver disease, liver transplant and those undergoing heart surgery, the FDA said. The most common adverse reactions were shortness of breath, chest discomfort, skin itchiness and rash, headache, and tingling sensations.

Octaplas is produced by Octapharma, based in Vienna, Austria.

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