It seems that rising Pradaxa bleeding reports, along with two recent warnings about the drug’s health risks for patients with artificial heart valves, may have caused Australian health regulators to change their tune about the blood thinner, according to

The FDA and Health Canada Issue Public Health Warnings about Pradaxa Bleeding, Other Side Effects

It was recently announced that warfarin, a similar blood thinner, was recommended over Pradaxa multiple times in a 153-page report on anticoagulation from Australia’s Federal Government. This news made headlines on Jan. 16, 2013, just a few weeks after the U.S. Food and Drug Administration (FDA) and Health Canada both issued public health alerts saying people with artificial heart valves may be more likely to suffer Pradaxa bleeding side effects and strokes.

Following these warnings, health agencies in the U.S. and Canada pledged their commitment to adjusting the labeling on Pradaxa to say the drug should not be prescribed to patients who underwent this procedure. On Dec. 21, Health Canada said it was working with the manufacturer, Boehringer-Ingelheim, to adjust the Canadian Product Monograph to include this important mention, while the U.S. Food and Drug Administration (FDA) said on Dec. 19 that the company would be sending a “Dear Doctor Letter” to all health care providers alerting them of this change.

In March 2011, Pradaxa was recommended by Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) for atrial fibrillation patients who may be likely to suffer a stroke or develop embolism.

If the agency rescinds its recommendation in light of Pradaxa bleeding side effects, the blood thinner may no longer be covered for patients under Australia’s government-sponsored health insurance plan.

Pradaxa Lawsuits

Pradaxa lawsuits have been filed on behalf of patients who allegedly experienced the following side effects after taking the blood thinner:

  • Gastrointestinal (stomach) bleeding.
  • Cerebral hemorrhage – Pradaxa bleeding in the brain.
  • Severe Pradaxa internal bleeding following a fall or similarly minor trauma.
  • Death from serious Pradaxa bleeding.

Many plaintiffs claim the maker of Pradaxa, Boehringer-Ingelheim failed to warn them of the risks associated with the drug.

Filing a Pradaxa Lawsuit? Call a Lawyer Today.

If you suffered Pradaxa bleeding or other side effects, it is imperative that you keep track of any medical appointments, and times absent from work you incurred as a result of your injury. You should also request copies of your medical records. This information is vital should you consider filing a Pradaxa lawsuit. Call an attorney at Bernstein Liebhard LLP at (877) 779-1414 for more information.

Published January 16, 2013 by