Pradaxa Linked to Serious Problems with Mechanical Heart Valves: FDA

According to a new warning issued by the FDA, individuals with prosthetic heart valves should not use Pradaxa, after data from a recently stopped clinical trial revealed that the newer blood thinner may increase the risk of strokes, heart attacks, blood clots and other serious problems.

In a Pradaxa safety warning issued on on December 19, the FDA indicated that Pradaxa is now contraindicated for patients with mechanical heart valves, stating that the drug should not be given to such individuals to help reduce the risk of strokes or major thromboembolic events.

The warning came in response to data from a clinical trial known as RE-ALIGN, which was recently cancelled in Europe to protect patient safety. The researchers found that using Pradaxa with mechanical heart valves increased the risk of heart problems and had a poorer outcome than giving them Coumadin (known generically as warfarin).

Before it was cancelled, the clinical trial revealed significantly more risk for Pradaxa users than those taking Coumadin. Pradaxa patients in the clinical trial had twice the risk of death, stroke or some other thromboembolic event overall. Major bleeding events affected 3.8% of Pradaxa patients, compared to 1.1% of those taking Coumadin.

“Health care professionals should promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication,” the FDA warned this week. “Patients with all types of prosthetic heart valve replacements taking Pradaxa should talk to their health care professional as soon as possible to determine the most appropriate anticoagulation treatment.”

Pradaxa Side Effects Leading to Investigations, Lawsuits

The warning is the latest blow to Boehringer Ingelheim’s blood thinner, which has been targeted by a growing number of lawsuits and safety investigations following hundreds of patient deaths.

Boehringer Ingelheim currently faces more than 120 Pradaxa lawsuits filed in courts throughout the United States on behalf of individuals who suffered serious bleeding problems. The complaints allege that the drug maker failed to adequately warn doctors and consumers about the risk of uncontrollable bleeding, due to the lack of a reversal agent.

Pradaxa (dabigitran) is an anticoagulant that was introduced by Boehringer Ingelheim in October 2010 for prevention of strokes in patients with atrial fibrillation.

The medication has been promoted as a superior alternative to warfarin (Coumadin), because it is easier to take and requires less monitoring.  However, it has been linked to a number of reports of severe bleeds and hemorrhages, as there is no antidote or reversal agent available to quickly stop the blood thinning effects of the medications.

Within the first year Pradaxa was on the market there were at least 2,367 adverse event reports submitted to the FDA involving bleeding problems among users of the medication, with 542 reports of death.  By comparison, warfarin was linked to 1,106 adverse event reports, including 72 patient deaths.

As a result of the inability to stop bleeding that may develop, some have suggested that a Pradaxa recall should be issued, since the risks may outweigh the benefits provided over warfarin.  However, there is no indication that U.S. regulators will remove the drug from the market, instead requiring stronger warnings about the risk of severe bleeding events.