Aminocaproic Acid Manufacturer Shuttered Though Not Expected to Trigger Shortage
Aminocaproic acid, which helps prevent the premature breakdown of blood clots, is often used to treat more minor bleeds in the nose or mouth.
Akorn Pharmaceuticals, one of several companies that manufactures and markets the product aminocaproic acid, recently filed for chapter 7 bankruptcy and subsequently closed.
For those unfamiliar with the product, aminocaproic acid is an antifibrinolytic agent that helps prevent the premature breakdown of blood clots. It is regularly used to treat more minor bleeds in the nose or mouth, and often prescribed in the lead up to dental procedures in patients with inherited bleeding disorders (IBDs) such as hemophilia, A and B, or von Willebrand disease. It is taken orally, in either tablet form or via a syrup solution, and often used in combination with another product such as factor replacement therapy. It can also be used to treat excessive menstrual bleeding in people with IBDs.
Fortunately, Akorn, which ceased all operations on February 24, 2023, is only one of several companies that manufactures and markets aminocaproic acid in both tablet and solution formulations. In fact, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has been working closely with these companies to help forestall any potential supply issues. Currently, it does not anticipate a shortage of aminocaproic acid tablets or oral solution based on what these companies are reporting relevant to both supply and production.
More specifically, the four firms that continue to manufacture aminocaproic acid tablets have reported that they anticipate being able to meet market demands for the product. In addition, while a company called Vistapharm recently discontinued the aminocaproic acid oral solution, remaining manufacturers of this formulation have indicated to the FDA that they will continue to support market demand.
CDER/FDA will continue to monitor the situation closely and to coordinate with these companies to prevent any shortages.
Please contact NHF at firstname.lastname@example.org, should you experience any challenges in accessing aminocaproic acid.
Read MASAC Recommendations Concerning Products Licensed for the Treatment of Hemophilia and Other Bleeding Disorders.
View the full list of products licensed in the U.S.
Learn more about current treatment options for bleeding disorders.
Source: National Hemophilia Foundation