In 2011, the U.S. Food and Drug Administration (FDA) announced that it approved the anti-clotting drug Xarelto® (rivaroxaban) to reduce the risk of stroke in people who have abnormal heart rhythm, or non-valvular atrial fibrillation. The FDA also approved Xarelto® to reduce the risk of blood clots, deep vein thrombosis, and pulmonary embolism following knee or hip replacement surgery. Xarelto® is manufactured by Janssen Pharmaceuticals, Inc., which is a subsidiary of Johnson & Johnson. Xarelto® is also co-marketed with Bayer AG.
According to the FDA, the safety and efficacy of the drug was evaluated in a clinical trial that was comprised of more than 14,000 patients. The trial compared Xarelto® to Warfarin, another anti-clotting drug. The trial found that Xarelto® was similar to Warfarin in its ability to prevent stroke.
Importantly, however, the trial also found that Xarelto® has many of the same side effects as other anti-clotting drugs. The most notable Xarelto® side effect is bleeding, which, in rare cases, may lead to death. Bleeding was found to be the most common adverse event reported in patients taking Xarelto®, and the risk of major bleeding was found to be similar to that of Warfarin.
In 2014, Bayer AG and Johnson & Johnson sought to expand the approved uses for Xarelto®. The drugmakers wanted to market Xarelto® as a drug that could prevent new heart attacks and strokes, and even death. The drugmakers also wanted to market the drug as having the ability to prevent clogging of heart stents.The FDA, however, denied the drugmakers’ request. Ultimately, the FDA found that clinical data was not strong enough to support the proposed claims.
In 2013 and 2014, the FDA required that Xarelto® drugmakers include boxed warnings. In 2013, the FDA required that Xarelto® include a warning that premature discontinuation of Xarelto® increases the risk of thrombotic events, and spinal/epidural hematoma. And in 2014, the FDA required that the drug must contain a warning that it can cause internal bleeding. The warning must also state that a specific antidote is not available for Xarelto®.
Since the drug has been approved by the FDA, thousands of individuals have suffered adverse side effects from taking Xarelto®. As a result of these Xarelto® side effects, more than a 1,000 people have filed lawsuits against the drugmakers claiming that they manufactured a defective drug and failed to warn the public about the drug’s possible dangers. The first few lawsuits are expected to go to trial in the beginning of 2017.
If you experienced a serious side effect while taking Xarelto®, reach out to an experienced Xarelto® attorney today to find out how to protect your legal rights. Your Xarelto® lawyer can also help you file a claim within the statute of limitations to ensure you have the highest chance of success.