A Kentucky man has added his lawsuit to the list of Xarelto claims that the blood thinner is dangerous.

Milford P. took Xarelto from mid-April 2016 until Dec. 3, 2016 when he suffered internal bleeding.

Xarelto (rivaroxaban) is made by pharmaceutical giants Bayer and Johnson & Johnson and was introduced in the U.S. in 2011 as one of the drug industry’s New Oral Anticoagulants (NOACs).

Pradaxa and Eliquis belong to this class as well. The NOACs have been promoted as a newer, better alternative to warfarin (Coumadin) because the NOACs only have to be taken once a day and no blood monitoring is required.

Xarelto Claims Include No Antidote Possible

Xarelto claims
in its marketing materials to have the “Xarelto Difference,” touting its single daily dosing, no blood testing requirements and no dietary constraints as big selling points.

Milford’s complaint argues “The use of Xarelto without appropriate blood monitoring, dose adjustment and twice a day dosing can cause major, life-threatening bleeding events.”

The “Xarelto Difference” was “aggressive and misrepresentative marketing” based on “flawed science” in order to boost sales, says the Xarelto claims complaint.

Uncontrollable bleeding can be a problem with any anticoagulant in the event of accident or injury, but warfarin has an antidote that stops its blood-thinning properties from continuing. Because warfarin can have its action reversed in an emergency, it has been used as a relatively safe medication to prevent stroke and systemic embolism for the past 60 years.

Because Xarelto has no antidote, the risk of severe or even fatal internal bleeding is heightened.

The Xarelto claims case says, “In the year leading up to June 30, 2012, there were 1,080 Xarelto-associated ‘Serious Adverse Event’ (‘SAE’) Medwatch reports filed with the FDA, including at least 65 deaths. Of the reported hemorrhage events associated with Xarelto, 8 percent resulted in death, which was approximately twofold the risk of a hemorrhage-related death with warfarin.”

In the first quarter of 2013, the number of SAEs associated with Xarelto was 680, more than Pradaxa’s 528. The latter had previously ranked as the number one reported drug on the SAE list in 2012.

Bayer and Johnson & Johnson stand accused of overstating the efficacy of Xarelto and of failing “to adequately disclose to patients that there is no drug, agent or means to reverse the anticoagulation effects of Xarelto, and, that such irreversibility could have permanently disabling, life-threatening and fatal consequences.”

The drug’s makers “also failed to warn emergency room doctors, surgeons, and other critical care medical professionals that unlike generally-known measures taken to treat and stabilize bleeding in users of warfarin, there is no effective agent to reverse the anticoagulation effects of Xarelto, and therefore no effective means to treat and stabilize patients who experience uncontrolled bleeding while taking Xarelto.”

The Xarelto Claims Lawsuit is Case No. 2:17-cv-07396-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.