Pradaxa Unsafe for Patients with Mechanical Heart Valves, Says FDA

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Pradaxa Unsafe for Patients with Mechanical Heart Valves, Says FDAOverview: The anticoagulant Pradaxa (dabigatran) should not be used in patients who have mechanical heart valves, according to the U.S. Food and Drug Administration (FDA). The agency has advised healthcare professionals to switch from Pradaxa to another medication in patients with mechanical heart valves.

  • The FDA has advised against using Pradaxa in patients with mechanical heart valves
  • Clinical trials in Europe were stopped because Pradaxa users were more likely to experience strokes, blood clots and heart attacks; there was also a higher risk of bleeding after valve surgery
  • Pradaxa is a blood thinner used to treat patients with atrial fibrillation

Product: Pradaxa (dabigatran)

Manufacturer: Boehringer Ingelheim Pharmaceuticals

Side Effects & Complications

  • Cerebral hemorrhaging
  • Gastrointestinal (GI) hemorrhaging
  • All types of bleeds including the intraspinal, intraocular, intraarticular (joints), retroperitoneal or pericardial areas

New FDA Warning

On Wednesday, the FDA issued a Drug Safety Communication warning against using Pradaxa in patients with mechanical heart valves, also referred to mechanical prosthetic heart valves. The agency stated that a clinical trial in Europe, called the RE-ALIGN trial, was recently halted due to an increased risk of blood clot, stroke and heart attack in patients taking Pradaxa compared to warfarin. The FDA also stated that there was a higher incidence of bleeding in Pradaxa patients after valve surgery.

Patients with valves made of natural biological tissue, known as bioprosthetic valves, were not studied and can therefore not be recommended, the FDA said. The agency advised healthcare professionals to which from Pradaxa to another medication in patients with mechanical heart valves. Patients should not stop taking a medication without consulting a doctor.

Pradaxa Background

Pradaxa is used to treat atrial fibrillation, a condition that causes an irregular heart rhythm. Blood thinners such as Pradaxa are intended to prevent blood clot, stroke and heart attack that can occur in this patient population. For decades, a medication called warfarin has been used to treat this condition, but dietary restrictions and the need for regular blood testing has given rise to a new generation of anticoagulants. Pradaxa, however, has its drawbacks; there is no antidote to reverse its effects. This means that if a patient experiences bleeding due to Pradaxa, there is nothing doctors can do to treat it. With warfarin, vitamin K can be used as a reversal agent.