On December 19, the U.S. Food and Drug Administration (FDA) released a safety announcement regarding the anticoagulant medicine known as Pradaxa. Pradaxa, known generically as dabigatran etexilate mesylate, is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc., a German pharmaceutical company.
The intention behind the FDA Pradaxa safety announcement is to inform health care providers and the public about the new risks associated with Pradaxa ingestion. In the release, the FDA warns that Pradaxa “should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves.”
The FDA’s recent safety announcement (comes) as data is being released from a European Pradaxa clinical trial, known as the RE-ALIGN trial. Researchers in the RE-ALIGN trial discovered that when patients using Pradaxa, versus those using warfarin, experienced an increased risk for stroke, heart attack, and blood clot development if these patients had mechanical heart valves.
Individuals with mechanical heart valves prescribed with warfarin did not experience such a significantly increased risk for the development of stroke, heart attack, or blood clot formation. Researchers in this European Pradaxa study also observed that patients experienced significantly more bleeding following valve surgery if using Pradaxa versus those using warfarin.
These findings from the European Pradaxa clinical trial clearly demonstrate the increased risk of serious bleeding and bleeding deaths, along with many other serious problems, associated with the use of Pradaxa.
As a result of these findings, the FDA made an urgent mandate that Boehringer Ingelheim update the medicine’s label to include a warning about the risks of using Pradaxa with a mechanical heart valve.
The FDA has already released a safety warning about Pradaxa in the past, with that FDA Pradaxa warning containing information about the high Pradaxa bleeding risk.
Pradaxa is prescribed to treat individuals suffering from non-valvular atrial fibrillation. Though intended to be a less burdensome miracle drug and a replacement for the antiquated warfarin, the reality of Pradaxa use has been fraught with serious bleeding risks and death.
If you or a loved one has suffered from serious bleeding episodes as a result of Pradaxa use, you and your loved one may be entitled to receive compensation for your emotional, physical, and financial losses. Attorneys at Carey Danis & Lowe understand the importance of consumer protection, and work hard with our clients to uphold justice and consumer rights.