Amid Mounting Xarelto Lawsuits, FDA Grants Priority Review to Low Dose Version

Published on July 5, 2017 by Sandy Liebhard

Xarelto may soon be available in a once-daily 10 mg dose, after the U.S. Food & Drug Administration (FDA) agreed to grant priority review of Janssen Pharmaceutical’s supplemental new drug application. The review comes as thousands of plaintiffs pursue Xarelto lawsuits for internal bleeding and other serious side effects allegedly associated with its use.

Xarelto Background

The FDA initially approved Xarelto in October 2011. The drug belongs to a class of novel anticoagulants which that been marketed as superior alternatives to a decades-old blood thinner called warfarin. Xarelto’s current indications include:

  • Prevention of deep vein thrombosis in patients undergoing hip or knee replacement surgery
  • Prevention of strokes in people with atrial fibrillation
  • To treat and reduce the recurrence of blood clots
  • To reduce the risk of stent thrombosis in patients with coronary artery disease

According to a press release issued by Janssen on June 28th, the 10 mg Xarelto dose would be indicated to reduce the risk of recurrent venous thromboembolism after at least 6 months of standard anticoagulant therapy. This serious clotting condition can lead to life-threatening deep vein thrombosis and pulmonary embolism.

The priority review designation reduces the standard review period from 10 months to 6.

“We are pleased the FDA sees the urgency in offering the choice of a 10-mg dose of Xarelto or the currently approved 20 mg dose. This will broaden the physician’s ability to customize treatment plans based on the needs of each patient,” Paul Burton, MD, PhD, FACC, Janssen’s Vice President for Medical Affairs, said in the June 28th statement.

More Than 17,000 Xarelto Lawsuits Pending

More than 17,000 Xarelto lawsuits are now pending in the U.S. District Court, Eastern District of Louisiana, where all federal claims involving the drug’s alleged bleeding side effects have been centralized for coordinated pretrial proceedings. Among other things, plaintiffs question Xarelto’s purported superiority over warfarin, arguing that internal bleeding associated with the older medication can be stopped via the administration of vitamin K.  There is currently no approved antidote to reverse Xarleto bleeding.

Plaintiffs further assert that Xarelto patients would benefit from a regular blood testing regimen to ensure proper dosage, which is standard with warfarin. Finally, they allege that the blood thinner was never subjected to adequate testing prior to coming to market and accuse Janssen and other defendants of failing to warn the public about Xarelto’s potentially deadly side effects.

Just two Xarelto lawsuits have gone to trial in Louisiana, both of which ended with defense verdicts.  A third case will go to trial on August 7th in the U.S. District Court, Southern District of Mississippi.

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