FDA approves Octaplas 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.
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.