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Last Wednesday, the FDA issued yet another safety alert regarding Pradaxa. This one warned healthcare providers that patients with mechanical heart valves should not take the blood thinner. According to Forbes writer Larry Husten, Pradaxa maker Boehringer Ingelheim will soon notify doctors via a Direct Healthcare Professional Communication (DHPC), in case they missed the FDA announcement.

Since being approved to treat atrial fibrillation in October 2010, Pradaxa has been linked to nearly 4,000 adverse side effects in this country, per the Institute for Safe Medication Practices’ May 2012 Quarterwatch report. Those side effects include 2,367 hemorrhages, 291 cases of acute renal failure, 644 strokes, 15 cases of liver failure, and 542 deaths.

Now, Boehringer has stopped the second phase of its RE-ALIGN clinical trial, which tested Pradaxa in patients with mechanical heart valves, according to, “because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin,” the FDA stated in a podcast. “There was also more bleeding after valve surgery in the Pradaxa users than in warfarin users.”

The FDA advised healthcare providers to switch patients with mechanical heart valves to another blood thinner. It also stated that Pradaxa users with any type of prosthetic heart valve should speak with their doctor as soon as possible; however, they should not stop taking the drug on their own, since that could increase their risk of developing a blood clot and/or suffering a stroke.

In light of the RE-ALIGN trial, Australia is now reconsidering whether to subsidize Pradaxa. According to a study titled “A cost-effectiveness approach to drug subsidy and pricing in Australia,” the government pays part of the cost for a list of medications. For a drug to be included on this list, its manufacturer has to show that it “is both clinically effective and cost-effective.”

The Australian Health Ministry stated, “In light of the latest clinical information … the net benefit of new oral anti-coagulants in clinical practice and the subsequent impact on cost-effectiveness is uncertain at this stage and the Pharmaceutical Benefits Advisory committee should review its March 2011 advice to list (Pradaxa) on the Pharmaceutical Benefits Schedule.”

If you or someone you know has been harmed by Pradaxa side effects, you should contact an experienced pharmaceutical defect lawyer today.

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