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Pradaxa Gets New Warning from FDA

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Brittany Nicole Hill5 years ago

The U.S. Food and Drug Administration (FDA) is warning doctors not to prescribe the blood thinner Pradaxa to patients with mechanical heart valves because of the risk of adverse events such as strokes, heart attacks, and blood clots. The new warning was issued on December 19, 2012.

Pradaxa Study Halted due to Risks

  • Boehringer Ingelheim recently conducted a clinical study (RE-ALIGN trial) which investigated the use of Pradaxa in patients with artificial heart valves.
  • The trial was halted when it became clear that Pradaxa users were more likely to experience strokes, heart attacks, and blood clots than those taking warfarin.
  • There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users.
  • Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems.

What is Pradaxa?

Pradaxa is a blood thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem.

Since its approval in 2010, Pradaxa manufacturer Boehringer Ingelheim has received hundreds of reports of fatal bleeding in patients taking the drug, including several cases ending in death.

Risks and Side Effects of Pradaxa

In certain cases, Pradaxa use can lead to serious, fatal bleeding. These risks are higher for:

  • Patients 75 years or older
  • Patients with kidney problems
  • Those with kidney problems who take dronedarone or ketoconazole
  • Patients with stomach ulcers
  • Those taking aspirin, or non-steroidal anti-inflammatory drugs and blood thinners
Contact an Experienced Pradaxa Attorney

Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of Pradaxa, contact Thomas J. Henry immediately. We are available 24/7, nights and weekends.


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