A woman from North Carolina has joined the multidistrict litigation over Xarelto alleging the anticoagulant medication caused her gastrointestinal bleed.

Plaintiff Tandy B. says she took Xarelto for only two months, from October to November 2014. She stopped taking Xarelto around the time she suffered a gastrointestinal bleed. She now alleges that bleed was caused by the blood thinner.

Tandy is filing this Xarelto blood thinner lawsuit against Bayer Pharmaceuticals, Janssen Pharmaceuticals, and Janssen’s parent company Johnson & Johnson. Janssen is the division of J&J responsible for the manufacture, marketing and sales of Xarelto.

Xarelto, also known as rivaroxaban, is a relatively new anticoagulant medication. It has been on the market in the U.S. since first earning FDA approval in 2011.

Xarelto is frequently prescribed to prevent the risk of stroke and systemic embolism in persons with non-valvular atrial fibrillation. It’s also indicated for the treatment and prevention of pulmonary embolism and deep vein thrombosis.

Litigation Over Xarelto

The controversy over Xarelto originates in the risk that Xarelto treatment can lead to excessive bleeding. The same anticoagulant action that makes Xarelto prevent stroke and embolism also inhibits the body’s natural mechanism for slowing and stopping bleeding when it occurs.

This effect can put Xarelto patients at risk for dangerous conditions like a brain hemorrhage or, as in Tandy’s case, a gastrointestinal bleed. Some instances of excessive bleeding have ended in death.

Tandy’s Xarelto blood thinner lawsuit notes that in a set of clinical trials known as the RECORD studies, Xarelto showed more frequent instances of bleeding leading to decreased hemoglobin levels and requiring transfusions of blood.

The claim also cites a later set of trials known as the ROCKET AF study. Results from those trials showed that patients who took Xarelto had more frequent gastrointestinal bleeds.

Tandy is challenging the rationale behind Xarelto’s once a day dosing schedule. The defendants designed and made Xarelto to be taken once a day, making Xarelto treatment simpler and more convenient than treatment with competitor drugs.

However, Tandy cites comments by FDA clinical reviewers questioning the once a day schedule, noting that clinical pharmacology studies suggested that dosing twice a day would produce less variance in Xarelto blood levels. One clinical reviewer suggested that the once a day schedule was promoted more for a marketing advantage than for any clinically significant reason.

A report published by the Institute for Safe Medication Practices also questioned the once a day Xarelto dosing, saying that peaks and dips in the blood level of Xarelto would be better tempered by twice daily dosing.

Tandy also notes that in Xarelto’s first full year on the market, the FDA received no less than 2,081 reports of adverse events associated with Xarelto. Out of those reports, 151 ended in death, Tandy says. She also notes that in the first eight months of 2013, German regulators received 968 reports of Xarelto-related adverse events, 72 of which resulted in death.

Tandy’s Xarelto blood thinner lawsuit is part of the Xarelto multidistrict litigation now pending in the U.S. District Court for the Eastern District of Louisiana under MDL No. 2592.