Eddie Farah Discusses the Potential Problems with Pradaxa

Posted on April 11, 2012

When the U.S. Food and Drug Administration (FDA) approved the drug Pradaxa in October of 2010, it was lauded as the less complicated alternative to Warfarin. Both drugs are used to treat patients who have non-valvular atria fibrillation (AF) — a common type of heart rhythm abnormality that can lead to stroke-inducing blood clots.

As an anti-anticoagulant medicine, Pradaxa was said to have advantages over Warfarin — namely, less frequent lab monitoring and fewer adverse interactions with other drugs. However, there was one big disadvantage when compared to Warfarin: once a bleeding episode started, it was harder to reverse. Warfarin has a specific antidote to stop bleeding episodes whereas Praxada does not.

Within weeks of Pradaxa’s release, there were 307 adverse event reports of bleeding and clotting associated with the drug. The large number of reports also revealed how quickly and how widely a new treatment could spread within a clinical setting.

Another disturbing trend was how quickly Pradaxa started being used “off label.” In other words, physicians were using the drug in a manner that was not approved by the FDA.

According to the Institute for Safe Medication Practices, there were more adverse effect reports associated with Pradaxa than any other monitored drug during the second quarter of 2011. Those reports included 117 deaths.

In response to the many adverse event reports the FDA had received concerning Pradaxa, the agency announced that is was initiating a safety review of Pradaxa in December 2011. The review process is still ongoing and the drug is still on the market.

Florida personal injury attorney Eddie Farah will be monitoring the ongoing adverse event reports associated with Pradaxa and the FDA’s safety review of the medication. If you believe you have sustained an injury related to Pradaxa or another potentially dangerous drug, Farah & Farah urges you to call (800) 533-3555 for a free consultation to discuss your legal rights and options.


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