Will Xarelto be Recalled from the Market Due to the Hemorrhage Risks?
Soon after it was introduced in November 2011, substantial concerns surfaced over the Xarelto hemorrhage risks, amid reports of severe and often fatal injuries associated with uncontrollable bleeds among users of the medication.
More than 20,000 complaints have been filed in state and federal courts throughout the country alleging that Bayer and Johnson & Johnson failed provide proper warnings for physicians or to fully investigate potential Xarelto antidotes, which may have allowed doctors to reverse the blood thinning effects of the medication if hemorrhaging developed.
Although many of the lawsuits have called for a Xarelto recall to be issued until a safe and effective reversal agent for the medication is proven to be safe and effective, it does not appear likely that the FDA will require the drug makers to remove Xarelto from the market.
It appears more likely that the U.S. regulatory agency may require stronger warnings instead of recalling Xarelto, with many calling for information about the hemorrhage risks to be placed in a “black box” warning, which is the strongest warning that can be placed on a prescription medication.
Informing potential users and the medical community about the current lack of an approved antidote for Xarelto and the importance of monitoring users during treatment to evaluate their risk of hemorrhages, may have prevented thousands of catastrophic injuries and deaths among Xarelto users.
Xarelto Antidote or Reversal Agent
It is also likely that Bayer and Johnson & Johnson will work hard to find an effective Xarelto reversal agent, or antidote that doctors can safely use to treat hemorrhages that occur among users of the medication.
Xarelto is part of a new class of anticoagulants, which have been promoted as superior alternatives to Coumadin, or warfarin, which has been the industry standard blood thinner for decades. Xarelto has been aggressively marketed as easier to use, because it does not require constant monitoring to ensure that users maintain the proper treatment.
While warfarin is considered harder, doctors do have an available reversal agent that can be used to reverse the blood thinning effects of the medication quickly, allowing blood to clot when problems develop.
If a similar reversal agent for Xarelto is identified and approved by the FDA, it would make the medication substantially safer. Many of the lawsuits over Xarelto currently being pursued not only allege that Johnson & Johnson and Bayer failed to adequately warn about the lack of a reversal agent, but also that they failed to fully investigate potential antidotes before marketing the drug.
Xarelto Recall Lawyers
The Xarelto lawyers at Saiontz & Kirk, P.A. are providing free consultations and claim evaluations to help determine if financial compensation may be available for individuals who have suffered severe injury or death as a result of:
- Uncontrollable Hemorrhaging
- Hemorrhagic Stroke
- Wrongful Death
As a result of the drug makers’ decision to place their desire for profits before consumer safety, Xarelto settlement offers may eventually be available.
All cases are reviewed by our attorneys under a contingency fee agreement, which means that there are no out-of-pocket expenses to hire our law firm and we receive no attorney fees or expense reimbursements unless we are successful in obtaining a recovery in your Xarelto lawsuit.