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New FDA Warning–No Pradaxa for Patients with Mechanical Heart Valves

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If you have had a heart valve replacement and are taking Pradaxa, speak to your doctor right away about your treatment. On December 19, 2012, the FDA issued a safety announcement warning physicians and the public that the blood-thinning drug Pradaxa (dabigatran) should not be used to help prevent blood clots and strokes in patients who have mechanical heart valves.

The warning came after researchers in Europe stopped their clinical trial because patients on Pradaxa who had mechanical heart valves were more likely to experience strokes, heart attacks, or blood clots than patients who were using the other blood-thinning medication, warfarin.

Since its FDA approval in 2010, Pradaxa has been associated with severe bleeding events. A report by the Institute for Safe Medication Practices indicated that the FDA had received over 500 adverse event reports related to the medication in the first quarter of 2011 alone.

FDA Warns Against Pradaxa Use in Some Patients

Pradaxa manufacturer Boehringer Ingelheim halted the phase II RE-ALIGN trial, because patients taking Pradaxa were experiencing more blood-clot related health problems than those taking warfarin. Researchers were testing three doses of the drug in patients with mechanical valves to see if Pradaxa might be a workable stroke preventative for them.

“Healthcare professionals should promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication,” the FDA stated.

The FDA has further instructed patients with bioprosthetic valves—those made from human tissue—to speak to their doctors about their options. The drug was not studied in these patients, so the FDA has no recommendation at this time. Daniel Simon, M.D., of Case Western Reserve University in Cleveland, however, told MedPage Today that if he encountered a patient with a natural biological valve, he would not prescribe Pradaxa.

Reports of Bleeding Problems with Pradaxa

Pradaxa was launched with a lot of excitement in October 2010. Approved for the prevention of strokes and blood clots in patients with atrial fibrillation, it was shown in pre-approval clinical studies to have a better success rate at reducing stroke risk than warfarin, a drug in use since the early 1950s. Boehringer Ingelheim marketed the anticoagulant as a more convenient alternative, since it does not require regular dose monitoring or a change in diet, like warfarin does.

Soon after the launch, however, the FDA began to receive reports of problems. Though both warfarin and Pradaxa carry a risk of excessive bleeding, doctors can stop that bleeding with warfarin by administering injections of vitamin K. Pradaxa has no such readily available solution, which makes bleeding risks much more dangerous and even deadly.

Concerns with Pradaxa Grow

In December 2011, less than two years after Pradaxa was released into the market, the FDA stated that they were evaluating reports of serious and fatal uncontrolled internal bleeding in Pradaxa patients. About a year later, on November 2, 2012, the agency stated that bleeding rates associated with Pradaxa did not appear to be higher than bleeding rates associated with warfarin, but they failed to address the lack of an antidote with Pradaxa.

Japan’s pharmaceutical regulatory authority required a boxed warning about the risk of severe hemorrhages with Pradaxa in August 2011. New Zealand alerted physicians to the lack of a reversal agent in September 2011.

Patients taking Pradaxa may also be at an increased risk for heart attacks, according to a Cleveland Clinic study. Patients on Pradaxa had a 33 percent higher risk of heart attack than those taking warfarin, according to researchers.

Meanwhile, over 100 plaintiffs who have suffered grave injuries associated with Pradaxa have filed lawsuits around the country. Thousands more are expected, with all federal lawsuits consolidated in the Southern District of Illinois.