Though it’s one of the newest blood thinners on the market, Xarelto is provoking lawsuit proceedings from many victims and their families. Blood thinners are inherently dangerous medications, and are responsible for a large number of adverse effects every year. Normally, though, they are monitored when used in patients, and that’s often not the case with rivaroxaban. There are other concerns with the drug as well, and its safety has been questioned by the FDA itself, and the agency has barred it from use in certain patients.
The primary fear with blood thinners like rivaroxaban and warfarin is uncontrolled bleeding. Because they interfere with the body’s blood coagulation response, even a small wound can become an emergency if the response is delayed. However, even with a quick response, rivaroxaban can still be deadly. That’s because, unlike warfarin, there is no antidote available to reverse the effects of rivaroxaban should it cause unchecked bleeding. Medical professionals have found that in an emergency, it can be extremely difficult to stop bleeding caused by the drug.
In 2011, rivaroxaban was approved by the FDA for use in patients at risk for deep vein thrombosis. However, by 2012, the agency was already receiving waves of adverse reports related to the medication’s use. In fact, in 2012 the FDA received three times as many rivaroxaban adverse reports than adverse reports related to warfarin use. These adverse reports generally involved internal bleeding, and in particular intestinal or brain hemorrhaging. However, there were also reports of embolisms and blood clots, so it’s not clear if the drug is doing what it is supposed to in some patients.
Another side effect related to rivaroxaban use, but one that gets less attention, is deep wound infections. One of the primary uses of the drug is to prevent blood clotting in patients recovering from surgery, but doctors have found that patients recovering from surgery were 10 times more likely to suffer from wound leakage and infection if they were prescribed rivaroxaban. Deep wound infections may produce life-threatening complications, and often require secondary surgeries to treat completely.
A unique feature of rivaroxaban is that it has a low therapeutic index. This means that the drug is designed to produce consistent effects across a spectrum of patients, regardless of their age, weight and gender. However, drugs with low therapeutic indexes can quickly become dangerous if dosing is exceeded or not manager properly. If rivaroxaban use was monitored closely by prescribing doctors, then this may be less of a concern, but unlike other blood thinners, rivaroxaban is marketed as the safe and convenient option that doesn’t need frequent monitoring, so this crucial safety check is often ignored.
Many people harmed by Xarelto have filed lawsuit actions against the drug’s manufacturer, Bayer. In general, they claim that Bayer knew about the risks, but continued to market the drug anyway. They also claim that patients are not adequately made aware of these risks, leading to dangerous use of the drug. Legal experts expect major settlements as a result of these proceedings, as comparable drugs have resulted in millions of dollars’ worth of damages.