Pooled blood plasma product OK’d in U.S.

The FDA has approved Octaplas, a pooled human plasma blood product for the replacement of coagulation factors in certain medical conditions where patients have insufficient levels. Clotting protein deficiencies can cause excessive bleeding or excessive clotting.

Octaplas (Octapharma, Vienna, Austria) 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 consequently minimizes the risk of serious virus transmission.

“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, MD, director of the FDA’s Center for Biologics Evaluation and Research, in a release.

Octaplas should be matched to the recipient’s blood group to help avoid transfusion reactions. With Octaplas, 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 2006.

The most common adverse reactions observed in clinical studies included shortness of breath, dizziness, chest discomfort, skin itchiness and rashes, headache and tingling sensations.