Product News and Recalls

Hundreds join Pradaxa blood thinner lawsuit

A report in USA Today concerns the legal action by hundreds of plaintiffs who used the blood-thinner Pradaxa, stating that it may amount to “the country’s next blockbuster civil settlement.”

The U.S. Food and Drug Administration approved Pradaxa, manufactured by German pharmaceutical giant Boehringer Ingelheim, in 2010. At the time, it was promoted as the first replacement for the commonly used blood thinner warfarin, known by the brand name Coumadin.

Millions of patients nationwide were prescribed Pradaxa because it doesn’t require weekly exams and dietary restrictions, as warfarin does.

But 3,781 adverse effects and 542 deaths associated with Pradaxa were reported to the FDA last year, surpassing all other monitored drugs. The FDA is now conducting a safety review of Pradaxa, and many physician groups and patient advocates have raised concerns about it.

Despite those concerns, Boehringer spent $464 million in 2011 to promote Pradaxa, including direct-to-consumer advertising. During the same period, the company’s sales topped $1 billion.

The report includes accounts of Pradaxa patients such as Roy Heady, a 65-year-old retired electrician. Shortly after switching from warfarin to Pradaxa, he was hospitalized for a hemorrhage.

He’s now off Pradaxa, but is still suffering from internal bleeding as a result of taking it.

Patients should consult their doctors before making any changes in their medication. A consultation with a Pradaxa lawyer is also important if there are significant injuries while on Pradaxa.

See the story here: