On August 19, 2012, The Tennessean newspaper reported that two Tennessee men were among hundreds around the country who blame the new blood thinner Pradaxa for internal bleeding events. Four days later, the drug’s maker, Boehring Ingelheim Pharmaceuticals, fired back with a letter to the editor owning up to the bleeding risk but arguing that the newspaper article omitted the drug’s proven benefits.

“The article failed to note that in a large clinical trial that involved more than 18,000 patients, Pradaxa was proven 36 percent better than warfarin at reducing the risk of stroke in patients with atrial fibrillation not caused by a heart valve problem,” the letter states.

Pradaxa was approved by the Food and Drug Administration (FDA) in 2010 to prevent strokes in patients with a heart condition known as atrial fibrillation. It was the first drug for that indication since warfarin was approved more than 50 years ago. The anticoagulant warfarin has numerous food and drug interactions and carries a risk for hemorrhaging, thus patients who are prescribed it must be monitored on a regular basis.

Studies did show Pradaxa was effective at preventing strokes in atrial fibrillation patients, and had fewer interactions, but it still left patients prone to internal bleeds.

A year after Pradaxa hit the market, not only did it celebrate blockbuster status with sales topping the $1 billion mark, it also gained a new title – the drug led all other medications in the number of deaths reported to the FDA in 2010, according to the nonprofit Institute for Safe Medication Practices.

“The drug has been under attack by physician groups and patient advocates since 3,781 adverse effects and 542 deaths associated with Pradaxa were reported last year to the Food and Drug Administration (FDA). The FDA is conducting a safety review of the drug, which millions of Americans take twice a day,” according to the August 19 story in The Tennessean.

“All blood thinners carry an increased risk of bleeding that should be balanced against an individual’s risk for stroke,” Boehringer Ingelheim wrote in its response. “With Pradaxa, there is a risk of serious and sometimes fatal bleeding, which is clearly stated in the U.S. prescribing information and in the patient medication guide that is distributed with every Pradaxa prescription,” according to the company response.

The drug company faces hundreds of lawsuits from patients who claim they suffered serious injury by using Pradaxa.

Source: The Tennessean

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3. Pradaxa patients exposed to higher cardiac risks, uncontrollable bleeding
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