Clinical Trials Show Pradaxa Drug Safety Concerns

Posted on December 9, 2011

According to news sources, safety concerns regarding the drug Pradaxa have led The Food and Drug Administration to caution healthcare providers about the safety of the drug after a large scale clinical trial found “serious bleeding events” related to the drug.

The FDA is currently in the process of attempting to identify if the drug causes more bleeding than what has commonly been expected. In a clinical trial including 18,000 patients found that those who took Pradaxa and warfarin experienced similar rates of major bleeding with both drugs, an FDA report said.

The Pradaxa label warns against significant or fatal bleeding associated with the dug.

The FDA has also said that patients with atrial fibrillation should continue taking the drug since stopping it would increase their risk of stroke.

Patients who have experienced any adverse effects due to the drug are encouraged to contact the FDA at 1-800-332-1088.

As a personal injury lawyer Los Angeles, I’m glad to see that research is continually being conducted to provide safer and more advanced drugs for the treatment of patients. I hope patients will find the conclusions of this study useful. If you or someone you care about has been injured or suffered from the use of an unsafe product, I recommend you contact a product liability lawyer Los Angeles as soon as possible.

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