A lawsuit alleges that a Delaware man suffered severe bleeding after taking Xarelto. According to the lawsuit, Freddie S., was prescribed Xarelto for the treatment of atrial fibrillation from July 5, 2012 to Dec. 20, 2016. The plaintiff says he suffered severe injuries from taking Xarelto, however, including gastrointestinal and rectal bleeding.
Ultimately, says the plaintiff, he was hospitalized and had to stop taking the drug. The lawsuit alleges that drug makers knew the risks of rectal bleeding from Xarelto, but failed to warn the public.
“Plaintiff brings this case against Defendants for damages associated with Plaintiff’s ingestion of the pharmaceutical drug Xarelto, which was designed, manufactured, marketed, sold and distributed by Defendants. Specifically, Plaintiff suffered various injuries, serious physical pain and suffering, financial expenses for hospitalization and medical care, among other damages, as a direct result of his use of Xarelto,” states the lawsuit.
According to the Xarelto lawsuit, drug makers, including Janssen, Bayer, and Johnson & Johnson, had an obligation to warn the medical community and the public about the risks of severe bleeding from taking Xarelto; however, says the lawsuit, the companies instead aggressively marketed the drug.
Xarelto was approved by the Food and Drug Administration on July 1, 2011. According to the lawsuit, that approval was based on flawed studies that were conducted negligently by the drug makers. The complaint points out that in a 2009 review of the studies drug makers used to support approval of the drug, the FDA found that one study regarding the use of was so flawed that its results had to be discarded.
An established safe treatment for preventing stroke and bleeding death exists, argues the lawsuit, that would not expose patients to risks of severe rectal bleeding.
Coumadin, also known as warfarin, has been in use for 60 years; however, warfarin requires blood monitoring and limitations to patients’ diets, according to the lawsuit.
However, drug makers marketed Xarelto as a more convenient alternative to warfarin. Xarelto was advertised as a single daily dose pill that does not require blood monitoring or changes in diet. But, alleges the lawsuit, research shows that it is safer and more effective if taken twice a day and while patients are undergoing blood monitoring.
“The use of without appropriate blood monitoring, dose adjustment and twice a day dosing can cause major, life-threatening bleeding events,” alleges the complaint.
Further, alleges the lawsuit “the Defendants were aware of this risk and the need for blood monitoring but have failed to disclose this vital health information to patients, doctors, and the FDA.”
Additionally, while there are antidotes to problems that may be caused by warfarin, there is no antidote to severe rectal bleeding and other risks presented by Xarelto.
If you or a loved one experienced rectal bleeding after taking Xarelto, contact the attorneys at McDonald Worley to evaluate your claim.