New information shows that Pradaxa’s manufacturer, Boehringer Ingelheim, failed to consider mechanical heart valve patients during clinical trials of the prescription anticoagulant medication.
The newly-revealed information confirms yet another problem in the studies, used to gain approval of Pradaxa for widespread use. Around 300,000 heart patients undergo valve surgery worldwide, and these same patients must frequently take anticoagulant medication.
The fact that Boehringer Ingelheim failed to consider this population when seeking approval for Pradaxa from the U.S. Food and Drug Administration (FDA) and other government agencies, as well as introducing the drug to markets, is yet another red flag for a medication and manufacturer that are under intense scrutiny for the circumstances surrounding Pradaxa’s approval.
Doyle Raizner is currently investigating claims arising from injuries caused by Pradaxa.