Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
Is Epsilon Aminocaproic Acid approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Epsilon Aminocaproic Acid in United States?
Wake Forest University Health Sciences is the originator. The local marketing authorisation holder may differ — check the official source linked above.