Lawsuits Over Failure to Warn About Xarelto Risks
Xarelto (rivaroxaban) is an anticoagulant that was introduced in 2011 as a replacement for warfarin and as a competitor to Pradaxa, prescribed for the prevention of strokes, deep vein thrombosis (DVT) and pulmonary embolism.
Although it has been promoted as safe and effective, reports suggest that side effects of Xarelto may substantially increase the risk of serious and uncontrollable bleeds, hemorrhages and death.
Information and warnings about these Xarelto risks have not been properly disclosed to consumers and the medical community, according to allegations raised in product liability lawsuits that were pursued throughout the United States.
Many severe injuries and deaths may have been avoided if proper warnings had been provided the Xarelto bleeding risks and the lack of an approved reversal agent to counteract the blood thinning side effects of the medication.
The Xarelto lawyers at Saiontz & Kirk, P.A. previously reviewed potential failure to warn cases for individuals and families throughout the country.
Xarelto Bleeding Risks
Xarelto is a member of a class of drugs known as “direct thrombin inhibitors.” The drug was jointly developed by Bayer and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary, and has grown into a blockbuster medication.
Since it was introduced in 2011, millions of Americans have been prescribed Xarelto to reduce the risk of stroke and blood clots associated with non-valvular antrial fibrillation, to treat deep vein thrombosis (DVT), to treat pulmonary embolism (PE) and to reduce the risk of DVT and PE following knee or hip replacement surgery.
The medication works by inhibiting the enzyme in the blood that causes clotting. However, with no approved antidote available to quickly reverse the blood thinning effects of Xarelto, doctors are often left unable to stop or control hemorrhages or bleeding that may develop among users.
Xarelto has been marketed as easier to use than warfarin (Coumadin), indicating that it is “the first and only once-a-day prescription blood thinner for patients with AFib not caused by heart valve problems, that is proven to reduce the risk of stroke – without routine blood monitoring.”
However, important safety information and warnings were withheld, despite evidence that Xarelto users have more gastrointestinal bleeds and need more transfusions.
Like all anticoagulants, Xarelto warnings do indicate that the medication carries a potential risk of bleeding. However, information provided is insufficient and does not accurately convey the serious and potentially deadly nature of these Xarelto side effects, according to allegations raised in lawsuits being pursued nationwide.
Although there is an Xarelto black box warning on the label about certain risks associated with the medication, information about uncontrollable gastrointestinal bleeds and hemorrhaging is not adequately addressed.
Black box warnings are typically used for the most serious risks associated with medications, placing the information prominently on the label to ensure patients and physicians are aware of certain side effects.
Information about the Xarelto bleeding risks were provided in the “Warnings and Precautions” section of the product label. However, these warnings failed to adequately disclose that side effects of Xarelto may cause uncontrollable bleeds and did not provide proper information for doctors about how they should stabilize patients if hemorrhages or bleeding occurs.
At the time they introduced the medication, Johnson & Johnson and Bayer buried mention about the lack of an Xarelto reversal agent in the full prescribing information, indicating that they did not test for all possible antidotes. Several years after the drug was approved, a reversal agent still was not available.
Even after the link between Xarelto and serious bleeds became evident in post-marketing adverse event reports, the drug makers continued to promote the medication as safe and effective, withholding information on the risk of irreversible bleeding.
In 2013, more than 700 adverse event reports submitted to the FDA involved risks associated with Xarelto, according to an analysis by the Institute for Safe Medication Practices (ISMP).
This number has continued to increase as Xarelto sales have increased, raising serious concerns about the long-term risks with Xarelto.
Rather than taking steps to recall Xarelto, provide stronger bleeding warnings or develop an effective antidote or reversal agent, marketing continued and the drug makers have pushed for expanded use of Xarelto.
Cases for Xarelto Hemorrhages and Bleeding Side Effects
Amid aggressive marketing by the drug maker, which withheld information from consumers and the medical community about the bleeding risks or lack of an effective reversal agent, Xarelto has become a top selling drug. Some estimates suggest that by 2018, Xarelto may be among the top 20 best selling drugs in the world, with sales expected to reach $3.7 billion.
Reports suggest that as use of the drug continues to increase, more and more people are suffering severe hemorrhages and bleeding events from side effects of Xarelto. In many cases, doctors are unable to control this bleeding, which has left thousands of users with severe and often fatal injuries.
As a result of the drug makers’ failure to warn about the risk of hemorrhages on Xarelto, financial compensation was pursued for former users through product liability cases. Families of individuals who suffered fatal bleeds were also entitled to benefits through an Xarelto wrongful death lawsuit.