The newest blood thinner on the market, Xarelto, has been hit with a double whammy. The FDA has disclosed that Xarelto maker Janssen Pharmaceuticals, Inc., has recalled 13,500 bottles of the medicine due to contamination. Contamination from what, neither the FDA nor the company has said. But it can’t be good. Meanwhile, there have been at least 20 lawsuits filed against the company for Xarelto-related side-effects, and the number is expected to grow.
From all reports, Xarelto has all the risks of Pradaxa, which has been linked to at least 500 deaths since its introduction four years ago. We at JJ&S aggressively pursued justice for our many Pradaxa victims, and I served as co-chair of the American Association for Justice Pradaxa Litigation Group. So I know how rushing these drugs to market before they are safe has hurt thousands.
Early reports about Xarelto, which came on the market in 2011, point to another epidemic of preventable injuries. According to the Institute of Safe Medication Practices, Xarelto now exceeds Pradaxa in both sales and reports of adverse side effects.
According to the ISMP, there were 680 serious adverse event reports linked to Xarelto, compared to 528 for Pradaxa in 2013, the latest year for this statistic. While the institute noted this is probably because Xarelto use was on the rise, researchers also noted another disturbing finding. Although Xarelto was being used primarily to reduce the risk of pulmonary and venous thromboembolism after hip and knee surgery, the biggest category of adverse events associated with the drug was serious thrombus, most often pulmonary embolism. In other words, the condition the drug was supposed to prevent was also its biggest side-effect.
Many older Americans depend on blood thinners to reduce their chances of blood clots, which can result in stroke. The biggest issue with both Xarelto and Pradaxa is that their blood thinning effects cannot be reversed if, say, a patient falls and starts to bleed, either internally or externally. In other words, there’s no antidote. A patient’s blood will not clot, increasing the risk of bleeding out.
Pradaxa’s manufacturer, Boehringer Ingelheim, this year settled some 4,000 Pradaxa injury cases against it for $650 million. The company reports it is working on an antidote.
Meanwhile, the FDA approved a new blood thinner, Eliquis (apixaban), in August. An FDA panel gave tentative approval to a fourth drug, Savaysa (endoxaban), last month. The jury is still out on these new arrivals.
The holy grail of anti-coagulants would be one whose effects could be reversed, and which doesn’t require extensive monitoring. All of us getting older should hope one is available soon.
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