May 3, 2012 — Pradaxa (dabigatran), Boehringer Ingelheim’s blockbuster anti-clotting medication, has been implicated in the deaths of at least 459 people. Most of the people who died were over the age of 80, and they suffered from serious internal bleeding or heart attacks. In spite of the life-threatening risks of Pradaxa, the drug is becoming more and more popular, with sales topping $603 million in 2011 alone.
The following rate of Pradaxa adverse events was reported for the third quarter of 2011 (July 1, 2011 through September 30, 2011):
- 2,958 serious adverse event reports in total linked to Pradaxa
- Of these events, 69 caused permanent disability
- 1,331 events resulted in hospitalizations
- In total, 459 deaths have been linked to Pradaxa, and there have been 12,480 adverse event reports linked to Pradaxa
- The most commonly-reported event is gastrointestinal bleeding, with at least 1,071 reports of Pradaxa patients suffering from this side effect
In an emergency situation, such as after a traumatic accident, a Pradaxa patient may start bleeding severely. Unfortunately, because their blood is unable to clot, even a doctor may not be able to stop the bleeding.
The anti-clotting effects of warfarin can be reversed with an injection of Vitamin K, but the only way to reverse the effects of Pradaxa is with dialysis. It takes several hours for dialysis to mechanically clear Pradaxa out of the bloodstream. By the time this occurs, a patient might bleed to death.
Furthermore, doctors may unwittingly prescribe Pradaxa to a particularly vulnerable population: People over 80 years old, who have impaired kidney function, and low body weight. According to a study from New Zealand, people with any of these risk factors have a much higher risk of severe internal bleeding.
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