Xarelto may cause dangerous health problems
Lawsuits have been filed against the maker of Xarelto (Janssen Pharmaceutical), as well as co-marketer Bayer Healthcare. These lawsuits allege that both physicians and patients were not warned about potentially fatal internal bleeding that could occur when taking the drug, and that patients may have died as a result.
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Xarelto is a blood-thinning drug (anticoagulant) commonly given to patients who have had a blood clot or who are at risk of blood clots. Patients who have deep vein thrombosis, pulmonary embolism, or atrial fibrillation, along with patients who have had a stroke, or a recent hip or knee replacement may have been given Xarelto. The drug is seen as an alternative option to Warfarin (Coumadin), which has been in use since 1954.
The Potentially Irreversible Risk
It is claimed that one of the largest concerns with Xarelto is that the internal bleeding it may cause may be irreversible. That can lead to death in patients who would be at less risk of a fatal bleeding event if they had chosen another type of blood-thinning drug. Warfarin, for example, may also cause internal bleeding. However, that bleeding can be treated with large doses of Vitamin K, and generally does not result in fatalities.
It is believed that it was not only the internal bleeding but the potentially irreversible nature of it that was on the minds of those who filed lawsuits against Janssen and Bayer, on behalf of the people who may have died from using Xarelto.
A large part of the lawsuit hinges on the possible irreversibility of that risk, stating that patients would have chosen to take Warfarin if they had been properly informed about the risks of Xarelto, and that physicians would have been less likely to prescribe the drug if they had been made aware of the severity of the bleeding concerns. While it is impossible to know how many physicians and patients would have chosen Warfarin if they had known about Xarelto’s possibly fatal internal bleeding risk, the claim that they were not provided with all the information to make a decision on a potentially deadly medication is at the heart of the lawsuits that have been filed.
Lawsuits Are in The Early Stages
Lawsuits against the makers of Xarelto have only recently been filed, and are still in the discovery stage. At this time, there has been no recall of Xarelto based on internal bleeding risk, and the drug is still being actively marketed and used. Those who are taking the drug should talk with their doctor about whether they should make a switch to another blood-thinning drug that may be a safer alternative.
The lawsuits filed make the following allegations as the basis for their Xarelto lawsuits:
- Xarelto manufacturers failed to warn about the risks of Xarelto, specifically the irreversible uncontrollable bleeding that may occur in some patients
- Xarelto contained a design defect in that it did not safely provide an anti coagulation solution, but instead posed greater risks to patients of internal bleeding due to no reversal agent
- Xarelto fraudulently concealed knowledge of irreversible life threatening events and how doctors should intervene and stabilize patients
- Xarelto manufacturers were negligent in placing the drug into the marketing knowing there was no antidote
- Xarelto manufacturers made a negligent misrepresentation in marketing Xarelto as a safe blood thinner
- Xarelto did not provide benefits greater than products that already existed in the marketplace in a safer manner such as Warfarin
The potential risk of internal bleeding from Xarelto may be different for each patient, but there is no currently known FDA approved antidote for the type of internal bleeding Xarelto may cause. It is also claimed that the drug may cause decreased hemoglobin, cerebrovascular accidents, hematomas, peripheral edema, difficulty breathing, and infection related to knee or hip replacement surgery.
While those side effects can be severe, it is alleged that information regarding the fact that they could occur was not made available to physicians and patients. The claimants sugges that had they been properly warned they could have made an educated decision on whether or not the benefits of taking Xarelto outweighed the risks for that particular patient. Since the potential risk of fatal internal bleeding was not provided in detail to physicians and/or patients, they were not able to make an informed decision, and that put patients at risk of adverse complications, including death. Anyone who believes they may have been injured by Xarelto or who may have lost a family member due to internal bleeding allegedly caused by the drug is encouraged to work with a lawyer to determine if a lawsuit should be filed on their behalf.