A blood thinner medication lawsuit has been filed against the makers of Xarelto.

Plaintiff Kathy S. says she took the prescription blood thinner from around Nov. 18, 2015 through Dec. 20, 2015. According to her blood thinner medication lawsuit, she suffered severely heavy menstrual periods and anemia that resulted in her needing blood transfusions on Dec. 21, 2015. She alleges Xarelto caused the excessive bleeding.

Xarelto, made by Johnson & Johnson subsidiary Janssen Pharmaceuticals along with Bayer Healthcare Pharmaceuticals, is one of the New Oral Anticoagulants (NOACs) with sales expected to top $1 billion this year.

Blood Thinner Medication Lawsuit Says Xarelto Ran Flawed Tests

The FDA approved Xarelto in July 2011. The manufacturers have promoted the drug as a better alternative to Coumadin (warfarin), which has been a trusted anticoagulant for nearly 60 years.

When taking Coumadin, the patient has to have INR (international normalized ration) blood tests to determine how fast the blood clots. The test ensures the right dosage is maintained.

In the event of a car accident or severe injury, Coumadin’s anticoagulant properties can be brought under control by a doctor administering a dose of vitamin K. All emergency room doctors are taught this protocol.

The blood thinner medication lawsuit alleges the studies that led to Xarelto’s approval were flawed and conducted negligently. The FDA found a “systemic discarding of medical records” and deemed what was called the RECORD 4 studies to be unreliable because of all the flaws.

Faulty management of a warfarin study group led the FDA to find fault with another study known as ROCKET AF. The blood thinner medication lawsuit alleges that because the warfarin group was so poorly managed, Xarelto appeared to be equal or better than warfarin.

“Another problem with the ROCKET AF study was Xarelto’s once-a-day dosing,” claims the blood thinner medication lawsuit. An FDA advisory committee determined that twice daily dosing would allow Xarelto to stay in the system at a more even level and might have been associated with greater efficiency and a better safety report.

The blood thinner medication lawsuit says that doctors have “to be able to balance the dose that the blood is thinned enough to reduce the risk of stroke, but not thinned so much as to increase the risk for a major bleeding event.”

The drug’s makers are accused of knowing the risk and the need for blood monitoring, but failing to notify patients, doctors and the FDA.

“Importantly, Xarelto’s significant risk of severe, and sometimes fatal, internal bleeding has no antidote to reverse its effects, unlike warfarin,” says the blood thinner medication lawsuit.

With no reversal agent available, doctors have no way to stop Xarelto’s blood thinning affects in the event of an accident or injury. From June 2011 to June 2012, the FDA recorded 1,080 Xarelto “Serious Adverse Event” reports. Of those, a minimum of 65 patients died. Of the uncontrolled bleeding events associated with Xarelto, eight percent ended in death, nearly two times the risk of a hemorrhage-related death with Coumadin.

If you or someone you love has been injured by Xarelto, you could qualify for a blood thinner medication lawsuit for compensation.

The Blood Thinner Medication Lawsuit is Case No. 2:17-cv-11686-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.