Report Suggests FDA Was Lax In Approving Pradaxa

A report issued by the Project on Government Oversight suggests that the U.S. Food and Drug administration (FDA), was lax in approving the anticoagulant Pradaxa, which has been allegedly linked to severe bleeding events. The investigation suggests that the FDA’s decision to approve Pradaxa was based off a single flawed trial that may have exposed patients to serious or life-threatening complications. Pradaxa was introduced in 2010 as a blood thinner meant to prevent strokes in patients with atrial fibrillation, Pradaxa blood thinner attorneys note.

If you or a loved one took Pradaxa and suffered complications, including internal bleeding, contact Attorney Group today to learn more about your options. We can answer your questions in a free, confidential, no-obligation consultation, and if you wish to pursue a claim, we can connect you with an affiliated Pradaxa lawsuit attorney.

Important: The time you have to pursue a claim is limited. Contact us for more information.

Report: Pradaxa Approval Was Based On One Clinical Trial

The investigation suggests that the FDA approved the blood thinner Pradaxa even though its effectiveness and safety weren’t clearly established. According to The International Business Times, the report, published in October 2015, found that Pradaxa was approved based on one trial that employed questionable techniques. Furthermore, the FDA allegedly permitted drug maker Boehringer Ingelheim to market Pradaxa as an effective alternative to Warfarin, even though the trial didn’t support this assertion.

According to the investigation, the trial was flawed in various ways. The FDA requested a blind trial, but Boehringer Ingelheim didn’t comply. The patients who took Warfarin during the trial didn’t follow proper usage directions, and some patients who developed adverse side effects from Pradaxa were allegedly removed from the study. Furthermore, the drug’s manufacturer didn’t decide how to analyze the findings until the trial was complete. The investigation concluded that all of these issues could have skewed the results.

In 2011 and 2012, Pradaxa was the most commonly named drug in adverse event reports made to the FDA, and in 2014 alone, more than 4,000 Pradaxa-related claims were settled, the website reported.

Injured Patients May Be Entitled to Compensation

Drug manufacturers have a duty to ensure their products are accompanied by full and accurate instructions and warnings to guide prescribing doctors and other health care providers in making treatment decisions. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.

Patients who have been injured by Pradaxa may be entitled to compensation for damages, including:

  • Medical expenses
  • Pain, suffering, and mental anguish
  • Loss of income or ability to work

If a patient dies from complications after taking Pradaxa, his or her family members may be able to pursue claims for their loved one’s wrongful death. Compensation may include:

  • Pain, suffering, and mental anguish from the loss of a loved one
  • Loss of financial support of a loved one
  • Funeral expenses

Affected patients are encouraged to speak with a Pradaxa lawsuit attorney to learn more about their rights and remedies.

Contact Us For More Information

If you or a loved one took Pradaxa and suffered complications, including internal bleeding, contact Attorney Group for more information. You can fill out the form on this page, call us at the number listed at the top of the page, or email us at

When you contact us, an attorney will follow up with you to speak with you about your case or answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.

Please note that the law limits the time you have to pursue a claim for an injury. If you think you have a case, you should not delay taking action.

See our Frequently Asked Questions page for more information, and contact Attorney Group today.