A woman has filed an intracranial hemorrhage lawsuit against the makers of Xarelto, alleging she got no adequate warning about the risks associated with this drug.

Xarelto is a one of the New Oral Anticoagulants (NOACs) that has become a big-selling blood thinner for pharmaceutical giants Johnson & Johnson, Janssen Pharmaceuticals and Bayer Healthcare.

Plaintiff Mary C. says she was prescribed the drug to prevent deep vein thrombosis and pulmonary embolism. When she suffered the intracranial hemorrhage, she says, she was hospitalized and told to stop taking Xarelto due to the injuries.

Intracranial Hemorrhage Caused by Lack of Clotting

One round of Xarelto’s initial clinical trials were known as the RECORD studies, which is short for Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism studies. According to Mary’ss complaint, the RECORD study showed that Xarelto was a better anticoagulant than Lovenox (enoxaparin) to prevent deep vein thrombosis after total knee and hip replacement surgery.

However, the study also reported Xarelto caused more episodes of bleeding, which rapidly decreased hemoglobin levels and resulted in the need for blood transfusions, says the intracranial hemorrhage lawsuit.

In 2009, the FDA said the RECORD studies were “flawed in design and conducted in a negligent manner” because of numerous violations, including the discarding of medical records, the falsification of records, and concerns about improper randomization. The FDA said the RECORD studies were not reliable, Mary says.

The intracranial hemorrhage lawsuit also faults the ROCKET AF study (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation).

The ROCKET AF study compared Xarelto to warfarin, a blood thinner that has been used for over 60 years. Warfarin, known by the brand name Coumadin, requires blood tests to ensure a safe and effective dose is maintained in the patient’s system.

The clotting effects of warfarin can be negated when the patient is given an IV dose of vitamin K, which is sometimes necessary in the event of an accident or injury that requires the bleeding to cease. Xarelto has no antidote to stop its anti-clotting effects.

According to the intracranial hemorrhage lawsuit, the warfarin group was so poorly managed in the ROCKET AF study that the results were considered invalid.

In 2012, the Institute for Safe Medication Practices said that during the FDA’s review process of Xarelto’s ROCKET AF study, “reviewers questioned the convenient once-a-day dosing scheme” of Xarelto because further studies had suggested that “peaks and troughs that could be eliminated by twice-a-day dosing.”

Dr. Steven E. Nissen, who was with the FDA at time, said, “My concern was that the dose was selected more for a marketing advantage rather than for the scientific data that was available, and was mistake…”

According to the intracranial hemorrhage lawsuit, the drug makers “failed to disclose the need for dose adjustments” and “failed to warn about the need for blood monitoring,” both of which could prevent or at the very least, reduce the likelihood, of catastrophic and potentially fatal bleeding.

The Intracranial Hemorrhage Lawsuit is Case No. 2:18-cv-00163-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.