Pradaxa

  • Pradaxa

Pradaxa (Dabigatran) is an oral anticoagulant prescribed to lower the chance of stroke for those suffering from atrial fibrillation (not caused by heart valve issues) and to treat blood clots in the veins of the legs (deep vein thrombosis) or lungs (pulmonary embolism) and reduce the risk of them occurring again. Pradaxa was introduced in the U.S. market in 2010, as an alternative to warfarin, after gaining an approval from the U.S. Food and Drug Administration (FDA). The drug is manufactured and marketed by a European pharmaceutical giant, Boehringer Ingelheim Pharmaceuticals, Inc.

Pradaxa is known as a "direct thrombin inhibitor," which lowers the chance of blood clots forming in the body by blocking thrombin - the blood's central clotting agent, thereby preventing nonhemorrhagic strokes and embolic events. It comes in 75 mg, 110 mg, and 150 mg capsules.

Within a year of introduction, adverse event reports of patients suffering from hemorrhaging, dyspepsia (abdominal pain, impaired digestion), gastrointestinal hemorrhaging and brain bleeding were received. When introduced, Pradaxa had no antidote; therefore, there was no way to control bleeding unlike Vitamin K used to reverse the effect of competitor warfarin.

In October 2015, the FDA granted an accelerated approval to Praxbind (idarucizumab), to allow doctors to reverse Pradaxa’s blood-thinning effects in emergency situations when bleeding can’t be controlled.

Serious Alleged Injuries may include:

  • Rectal bleeding
  • Intestinal bleeding
  • Brain hemorrhaging
  • Death caused by uncontrolled bleeding
  • Paralysis, if the user has a spinal tap or an epidural

FDA SAFETY WARNINGS:

Bleeding warning information was provided by the FDA on the label to the public when introduced in 2010, stating only “Pradaxa can cause serious and, sometimes, fatal bleeding.”

In 2011: FDA announced it was evaluating post-marketing reports of serious bleeding among Pradaxa users. Later, FDA claimed the results of its study of bleeding events were similar to the data from the RE-LY trial conducted for clinical drug approval but that the FDA was continuing to evaluate multiple sources of data. However, the FDA did not change its recommendation for Pradaxa, nor did it change the label, or add information noting that unlike warfarin, there is no antidote to Pradaxa.

In 2012: On December 19, the FDA released a safety announcement regarding Pradaxa that it “should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves.”

In 2013: The Company announced the first black box warning, alerting patients that discontinuing Pradaxa without adequate anticoagulation increases the risk of stroke and an increased risk of spinal hematomas in some patients.

In 2015: The FDA issued a safety communication stating that the blood thinner caused a higher risk of gastrointestinal bleeding than warfarin (although, it had a similar risk for myocardial infarction and a lower risk for ischemic stroke, intracranial hemorrhage, and death).

Currently, Pradaxa is the only blood thinning medication with an FDA approved antidote.

Lawsuit Allegations:

In August 2012, MDL No. 2385 in re: Pradaxa (Dabigatran Etexilate) Products Litigation was created by the U.S. Judicial Panel on Multidistrict Litigation to be convened in the Southern District of Illinois and to be presided by Judge David R. Herndon. Nearly 21 legal actions were transferred to this MDL, and thousands of lawsuits continued to be filed touching the count of approximately 4,000.

In 2014, the judges overseeing the cases approved a $650 million settlement between the defendants and plaintiffs. A settlement fund was established from which victims could be paid. Additionally, a small portion of the fund was designated to cover legal and administrative costs.

Evidences:

  • Indication of usage in Medical Records
  • Duration of Usage
  • Complications and their treatment after intake

Medical Record Review and claim validation of Pradaxa case should take approximately 4 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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