Pradaxa clinical trial issues

More than 18,000 patients participated in a clinical trial comparing Pradaxa and Coumadin. Major bleeding events occurred at similar rates with both drugs.

In the clinical trial, patients taking Pradaxa had fewer strokes than those who took Coumadin. On October 19, 2010, the FDA approved Pradaxa 75 mg and 150 mg capsules for the prevention of stroke and blood clots in patients with abnormal heart rhythm or AF. Pradaxa is made by Boehringer Ingelheim Pharmaceuticals Inc. of Ridgefield, Conn.

As with other approved blood thinner drugs, bleeding, including life-threatening and fatal bleeding, was among the most common adverse reactions reported by patients treated with Pradaxa. Gastrointestinal symptoms, including stomach pain, nausea, heartburn, and bloating were also reported.

A report of about 50 cases of fatal bleeding worldwide associated with the drug surfaced in November 2011. On December 7, 2011, slightly more than one year later of approving Pradaxa— the FDA announced that despite post marketing reports of severe bleeding – patients should continue to take Pradaxa.

However, during the clinical trial, 110 mg and 150 mg capsules were tested not 75 mg. How can one dose be tested in a Pradaxa clinical trial and another dose released into the pharmaceutical marketplace without testing? Is that ethical?

In an article published by the New England Journal of Medicine, AF patients taking 150 mg twice a day of Pradaxa had lower rates of hemorrhagic stroke and ischemic stroke than patients taking Coumadin.

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Conversely, while the 150 mg reduced the risks of stroke, it caused more bleeding.

What's wrong with this picture? If you or a family member has suffered severe bleeding from Pradaxa – please contact Anapol Schwartz as you may be entitled to a Pradaxa bleeding lawsuit.