A consumer recently filed a lawsuit against numerous pharmaceutical companies, alleging that Xarelto dosage side effects caused adverse health effects and uncontrollable bleeding.

Plaintiff Sandra S. recently filed a lawsuit against Janssen, Johnson & Johnson, and Bayer, alleging that Xarelto dosage side effects can be dangerous and were not sufficiently warned by the pharmaceutical companies.

In 2014, Sandra says she was prescribed Xarelto for the treatment of her blood clots. She took the drug through 2016, at which point she allegedly suffered from Xarelto dosage side effects including uncontrollable internal bleeding.

Xarelto (rivaroxaban) is a modern anticoagulant which is prescribed to prevent or manage clotting in a variety of at-risk patient populations. The drug was approved by the U.S. Food and Drug Administration (FDA) in 2011 for a variety of uses. Although the drug was approved, clinical trials showed that Xarelto may be dangerous and likely to cause bleeding.

The RECORD studies were initiated to compare the performance of Xarelto to that of warfarin, the industry standard blood thinner. Although the studies showed that Xarelto was non-inferior to warfarin, data showed that “bleeding from gastrointestinal sites, including upper, lower, and rectal sites, occurred more frequently in the rivaroxaban group, as did bleeding that led to a drop in the hemoglobin level or bleeding that required transfusion.” Sandra claims that the Xarelto dosage side effects exemplified in the RECORD studies prove that the product is defective and dangerous.

The blood thinner lawsuit further alleges that Xarelto dosage side effects are not only the product of a defective drug. Sandra claims that the defendants made decisions regarding the dosage system for Xarelto in order to maximize potential profits. This decision was allegedly made without considering that the once a day dosing system dramatically increased the chances of an uncontrollable bleeding event.

The problem is allegedly well known by the medical community and understood by regulators such as the FDA. In 2012, the Institute for Safe Medication Practices noted that FDA reviewers during the approval process “questioned the convenient once-a-day dosing scheme [of Xarelto], saying blood level studies had shown peaks and troughs that could be eliminated by twice-a-day dosing.”

Sandra claims that the defendants knew their drug was safer with twice a day dosing but chose to implement a once a day dosing system in order to make the drug more competitive than blood thinners, such as warfarin, which require twice a day dosing.

This decision has reportedly caused thousands of adverse bleeding events related to Xarelto dosage side effects. By the end of 2012, the first full year the drug was on the market, there had been 2,081 serious adverse event reports filed with the FDA. Of the bleeding events reported, eight percent resulted in a death.

“Despite the clear signal generated by the SAE data, Defendants failed to either alert the public and the scientific community, or perform further investigation into the safety of Xarelto,” the Xarelto dosage side effects lawsuit states.

The Xarelto Dosage Side Effects Lawsuit is Case No. 2:18-cv-08199-EEF-MBN and is part of the Xarelto MDL, In re: Xarelto (rivaroxaban) Products Liability Litigation, MDL No. 2592, in the United States District Court for the Eastern District of Louisiana.