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Pradaxa Approved by FDA: A New Drug to Prevent Stroke
by admin on: July 29th, 2011

Pradaxa, a drug also known as dabigatran etexilate, was granted approval in October 2010 by the U.S. Food and Drug Administration (FDA) for use as a treatment for the prevention of stroke and blood clots (systemic embolism). This drug is indicated for patients that are diagnosed with a condition referred to as atrial fibrillation (abnormal rhythm of the heart). This drug was discovered and subsequently developed by researchers at the pharmaceutical company Boehringer Ingelheim in Ridgefield, Connecticut.

Pradaxa is classified as a direct thrombin inhibitor and, as such, it is the first new oral anticoagulant that gained approval to be sold in U.S. markets in over 50 years. As an anticoagulant, the mechanism of action for Pradaxa is to inhibit the enzyme in the blood that is involved in clotting processes (this enzyme is called thrombin).

The clinical trials for Pradaxa involved over 18,000 patients; to date, this is the largest prevention trial that has been conducted in patients with atrial fibrillation (more specifically, the patients were diagnosed with non-valvular atrial fibrillation).

Pradaxa was compared with the drug Warfarin. Patients that were administering Pradaxa had fewer strokes compared to the patients given warfarin. Of note, patients administering warfarin are required to have periodic monitoring via blood tests; Pradaxa does not have any requirements for periodic monitoring through blood tests.

Pradaxa will be available in capsules containing either 75 mg or 150 mg of the drug. Similar to other FDA-approved anti-clotting drugs, patients taking Pradaxa may experience the following serious adverse effects during Pradaxa therapy:

  • bleeding
  • life-threatening bleeding
  • fatal bleeding
  • bloating
  • heartburn
  • nausea
  • stomach pain
  • uncomfortable feeling (referred to as dyspepsia) in the stomach

As a result of the potential consequences of Pradaxa therapy, this drug is contraindicated in patients that present with active pathological bleeding and patients that have a history of hypersensitivity reaction to this drug.

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