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FDA Has Twice Ordered Black Box Warnings for Xarelto

Jul 7, 2016

Since the Food and Drug Administration (FDA) approved the new-generation blood-thinning drug Xarelto in 2011, the agency has ordered two separate black box warnings for Xarelto.

Black box warnings-where the information is enclosed in a black box to draw attention -are the FDA's most serious label warnings. A black box warning is sometimes the precursor to a drug being removed from the market.

Xarelto (rivaroxaban) was approved to treat patients at risk for blood clots from medical conditions such as atrial fibrillation, pulmonary embolism, and deep vein thrombosis, and for people at risk for blood clots during recovery from knee and hip replacement surgeries.

Since Xarelto came to market, it has become a popular alternative to the older blood thinner, warfarin, Digital Journal reports. This popularity is due in part to the freedom Xarelto users have from the regular blood testing and dietary restrictions required of warfarin users. But there is an important difference between Xarelto and warfarin. Though warfarin users have serious restrictions-regular blood testing and careful diet-there is an antidote that can be given in the event of a bleeding episode. Xarelto has no known antidote, and many Xarelto users say the drug makers put them at risk by bringing the drug to market without an antidote.

More than 3,400 lawsuits have been filed against Bayer AG and Janssen Pharmaceuticals, the manufacturers of Xarelto, alleging bleeding episodes that have caused injuries and deaths. The lawsuits, which come from all across the country, have been consolidated into two primary groups. Twenty-eight hundred federal cases have been consolidated in a multidistrict litigation (MDL) in the Eastern District of Louisiana, overseen by Judge Eldon Fallon. The second group (more than 600 cases) is a mass tort program in the Court of Common Pleas in Philadelphia.

Many of the Xarelto lawsuits note that the drug makers heavily promote Xarelto's convenience while omitting the risk created by the lack of an antidote. Celebrity Xarelto users like golfer Arnold Palmer and basketball all-star Chris Bosh speak about the ease and freedom they enjoy with Xarelto without mentioning the risks. A number of plaintiffs say Janssen and Bayer were reckless in not informing potential Xarelto users of the danger they could be in if they have a bleeding episode and they say they would have asked their doctor about other treatment options if they had been aware of the seriousness of Xarelto's bleeding risks.

In addition, there is controversy over the clinical trial that was a basis for the drug's approval. The trial is being questioned because of the use of a recalled blood-testing device. Inaccurate readings may have resulted in warfarin users getting an incorrect dose. Incomplete information was sent to regulators and to the New England Journal of Medicine (NEJM), whose assessment of Xarelto (rivaroxaban) based on this faulty testing data likely led to FDA approval.

In addition, the plaintiff in a Xarelto lawsuit filed in October 2015 alleges that the daily Xarelto dose, the same dose for all patients, regardless of size or weight, is not an effective amount for every patient. The plaintiff said he suffered a stroke only four days after beginning to take Xarelto to reduce the risk of stroke due to atrial fibrillation, Digital Journal reports.

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