Pradaxa and FDA Warning

Serious bleeding events associated with Pradaxa patients

In light of recent data, some have questioned the Food and Drug Administration’s decision to approve Pradaxa for U.S. markets in 2010. This marked the first time in decades that a new anticoagulant drug had been approved. While the FDA’s initial approval was based in no small part on extensive Pradaxa testing conducted by its manufacturer, the results of these tests have since been called into question. While this has prompted a Pradaxa FDA alert to the medical community no recall has yet occurred. But so long as people continue to suffer disproportionately adverse effects while taking Pradaxa, the attorneys of the Phillips Law Offices will be standing by to help them get justice.

Pradaxa’s path to approval

Since the FDA approved warfarin over 50 years ago, the bleeding risks associated with anticoagulant treatments have been well known in the medical community. Initial Pradaxa testing, which included a clinical trial of 18,000 patients, suggested that the bleeding side effects of Pradaxa were similar to those of warfarin.  The FDA relied heavily upon this trial in reaching its decision to approve the drug and continues to cite it in support of the very limited action it has taken subsequent to the initial Pradaxa FDA approval date.

After Pradaxa hit the market in 2010, reports began to surface about serious bleeding events linked to the drug. Physicians became troubled that Pradaxa, unlike its predecessor warfarin, did not have a counterpart that could reverse its anticoagulant effects in case of a serious bleeding injury. Then in October of 2011, the drug’s manufacturer announced it had received over 250 reports of Pradaxa related bleeding deaths. The first Pradaxa lawsuits followed in November and the Pradaxa FDA alert was issued in December. Presently, however, the Pradaxa FDA investigation continues and a recall has yet to occur although some scholarship has indicated that bleeding events are significantly more common for Pradaxa patients than those taking warfarin.

We are Illinois lawyers who know Pradaxa litigation issues

The experienced Pradaxa attorneys at the Phillips Law Offices have closely followed the legal and medical developments surrounding Pradaxa since the beginning. We understand the issues and know how to get clients injured by Pradaxa the compensation they deserve. Call us today at (312) 346-4262 or contact us online to schedule a free consultation with a knowledgeable attorney. You can count on us to be by your side throughout the course of your pharmaceutical liability case.