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For years, doctors recommended warfarin, an anticoagulant, to prevent blood clots in those suffering from atrial fibrillation. Warfarin works by decreasing Vitamin K in the blood, and in case of emergency, doctors would administer a dose of Vitamin K.
Yet, warfarin is far from perfect. Its side effects have included brain hemorrhages and internal bleeding, making it one of the leading causes of emergency room fatalities. Furthermore, those taking it often have to follow stringent dietary restrictions.
Because of this, a new class of anticoagulants emerged in 2010 with Pradaxa, then hailed as an improved blood thinner that required less maintenance. Yet, two years after the FDA’s approval, reports show Pradaxa associated with over 500 deaths.
Unlike warfarin, Pradaxa and other new anticoagulants limit production of thrombin, a clotting protein in the blood. No known antidote exists, and patients, even after experiencing a minor injury, risk life-threatening, uncontrolled bleeding.
Occurring externally and internally, this side effect may lead to:
- Stroke
- Retinal hemorrhages
- Death
- Intracranial hemorrhages
- Pulmonary embolism
- Decreased hemoglobin
- Gastrointestinal hemorrhages
- Deep vein thrombosis
- Adrenal bleeding
Multiple anticoagulants currently remain on the market:
Pradaxa
As the first of the new anticoagulants, this drug generically known as dabigatran has a warning label about increased bleeding levels. Along with this risk, discontinuing it suddenly or missing a dose raises a patient’s level of a stroke.
In its introduction, manufacturers highlighted how patients would no longer need to monitor blood levels. Likely as a result, 16 percent of all patients managing atrial fibrillation took Pradaxa a year later.
Because of the high number of associated deaths, plaintiffs alleged manufacturer Boehringer Ingelheim did not provide adequate warning about side effects. In 2014, the company settled more than 4,000 lawsuits for $650 million.
Xarelto
Approved in 2011, this drug generically known as rivaroxaban is associated with the same risks. However, in 2013, the FDA warned the manufacturer about its print advertisements, and later rejected Johnson & Johnson and Bayer’s expansion proposal.
Eliquis
The FDA approved this anticoagulant, known as a direct factor Xa inhibitor, in 2012. While the drug’s in a separate class, it is associated with the same side effects as Xarelto and Pradaxa.
Zontivity
As the newest anticoagulant, Zontivity (vorapaxar) entered the market in 2014. Yet, it debuted with a troubled start, as signs of severe bleeding stopped early trials. Because of this factor, the FDA requires the drug to carry a boxed warning about intracranial hemorrhaging.
