The FDA has announced the approval of Tretten for basic prevention of bleeding in adults and children who have a rare clotting disorder, known as congenital Factor XIII, an extremely rare genetic disorder in which they do not produce enough of the protein Factor XIII needed for normal clotting.
“The approval of this product provides another therapeutic option for the prevention of bleeding in patients with Factor XIII A-subunit deficiency,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “Without treatment, people with this rare condition are at risk of bleeding to death.”
According to clinical trials, Tretten was effective in preventing bleeding in 90% of the patients when given monthly, and did not cause anyone taking it to develop any abnormal clotting, according to Midthun. However, some of the participants did report headaches, and pain at injection site.
To learn more contact the FDA consumer line at 888-INFO-FDA