New Pradaxa Contraindication Coming
Boehringer Ingelheim is warning doctors about using its Pradaxa (dabigatran) blood thinner drug for patients with mechanical heart valves.
Pradaxa is used to prevent stroke and blood clots in patients with abnormal heart rhythm. However, Boehringer Ingelheim will issue a contraindication for patients with mechanical heart valves, according to a recent article in Forbes. A contraindication is something (such as a symptom) that makes a particular treatment inadvisable. The company will make this contraindication update via a “Dear Doctor Letter,” also called a Direct Healthcare Professional Communication (DHPC).
The Pradaxa contraindication was based on a recent decision of the U.S. Food and Drug Administration (FDA), said Boehringer Ingelheim. The agency apparently based its decision on findings from the so-called “Re-Align” trial, which followed patients with mechanical heart valves. Additionally, Boehringer Ingelheim recently announced it ended the Re-Align trial prematurely.
Since the FDA approved Pradaxa in 2010, the drug has been associated with many problems—including serious and potentially fatal bleeding. Millions of Americans take Pradaxa—and may be putting themselves at high risk of serious injury and death.
If you or a loved one has been injured by Pradaxa, you may be entitled to compensation. Contact a Pradaxa lawyer at Sokolove Law today for a free legal consultation. Sokolove Law is an experienced Pradaxa law firm, with Pradaxa attorneys ready to help get you the compensation you deserve.