Aug 18, 2014 9:00 AM

Author: Office of Public Affairs


Update: Boehringer Ingelheim released a statement regarding the report in The BMJ. Read it here.

If you take the blood thinner Pradaxa, recent news may have left you concerned about its safety.

Pradaxa’s manufacturer, Boehringer Ingelheim, may have knowingly withheld information about risks associated with it, according to published reports in medical journal The BMJ.

Pradaxa, prescribed to people at risk for stroke due to atrial fibrillation, was originally touted as having a lower risk than the standard treatment, warfarin, known by the brand name Coumadin. The Food and Drug Administration approved its use without the need for frequent blood tests. But new evidence suggests frequent testing may reduce the risk of serious, sometimes fatal, bleeding events.

"Boehringer Ingelheim has failed to share with regulators information about the potential benefits of monitoring anticoagulant activity and adjusting the dose to make sure the drug is working as safely and effectively as possible," Deborah Cohen, The BMJ’s investigations editor, wrote in the report.

Gregory Hawryluk, MD, PhD, a neurosurgeon at University of Utah Health, says Pradaxa may now be a less attractive option than Coumadin.

“The fact that monitoring wasn’t recommended for Pradaxa was one of the main reasons that physicians prescribed it in the face of the difficulties reversing or neutralizing it,” he explains, noting a reversal agent for Pradaxa is currently in clinical trials. Coumadin, meanwhile, is readily reversible.

People taking Pradaxa who are thinking of stopping because of the controversy should speak to their doctors first. “It is very important that patients who are taking Pradaxa continue taking it as prescribed by their physician,” Hawryluk says. “It is very clear that although there are unavoidable risks inherent to Pradaxa, Coumadin and similar agents, the risks of treatment with these drugs as they are currently prescribed and monitored is lower than the risk of stroke that patients would face without them.”

The FDA agrees. A spokeswoman tells WebMD that the agency still believe that Pradaxa provides an important health benefit and recommends that health care professionals follow the recommendations on the approved drug label.

“Treatment with either Pradaxa or Coumadin is clearly better than no treatment,” Hawryluk says.

pradaxa stroke atrial fibrillation

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