Xarelto Bleeding Antidote Approved by the FDA

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An antidote to the unintended side effect of the drug Xarelto, uncontrolled bleeding, has finally been approved by the Food and Drug Administration (FDA) in the United States.

The Xarelto bleeding antidote comes after numerous reports and litigation over one of the drug’s most terrifying side effects – uncontrolled bleeding.

It is reported that nearly 120,000 people were admitted to the hospital in 2016 with uncontrolled bleeding after taking Xarelto and similar drugs.

Andexxa, the Xarelto bleeding antidote, is made by Portola Pharmaceuticals. The drug maker faced several delays and was even denied by the FDA in 2016.

“We are grateful to the patients who participated in our trials, our clinical trial collaborators, our employees and the FDA for their help in bringing this new drug to market for the benefit of patients with Factor Xa inhibitor-related bleeding,” said the CEO of Portola, according to drugwatch.com.

If you or a loved one suffered Xarelto bleeding or other side effects, consider talking to the attorneys at McDonald Worley to evaluate your legal options.

Xarelto Bleeding Antidote

The Xarelto bleeding antidote does not come without risks. The most common are urinary tract infections and pneumonia; however, some of the patients who took part in the fast track clinical trial of Andexxa faced additional serious side effects, including;

• Deep vein thrombosis
• Arterial Systemic embolism
• Heart Attack
• Stroke
• Pulmonary embolism
• Death

A warning about these risks will be put on the box of the Xarelto bleeding antidote.

Andexxa was designated an “Orphan Drug” under FDA regulations. The makers of the Xarelto bleeding antidote will be required to monitor at least 440 patients in a post market study due in 2023 after the drug is launched.

While the Xarelto bleeding antidote will only be released on a limited scale in June, the drug maker expects to make it commercially available in early 2019.

Xarelto Uncontrollable Bleeding

Since its introduction to the market as a next generation anti-clotting drug, Xarelto has been associated with uncontrollable bleeding. While bleeding caused by its predecessor, warfrin, could be controlled, there was no Xarelto bleeding antidote when the drug came to market.

The drug makers faced patient complaints and ultimately litigation over the lack of a Xarelto bleeding antidote. Patients allege that they and their doctors were never warned about the potential for uncontrollable severe bleeding as a side effect of the drug.

Instead of warning patients and their doctors about the risk of uncontrolled bleeding, Xarelto lawsuits allege that the pharmaceutical companies marketed the drug as simpler and less intrusive than warfarin because Xarelto did not require blood testing or multiple daily doses; however, patients point to studies in their lawsuits that demonstrated Xarelto was safer and more effective with monitoring.

Sadly, for a number of patients, uncontrolled bleeding events from Xarelto were fatal. Other patients suffered serious side effects as well, including irregular heartbeat and cardiac events.

Symptoms of Xarelto side effects include weakness, numbness, and faintness. Patients have also reported headaches and stomach problems.

While the Xarelto bleeding antidote may help future patients, those who suffered risks they may not have known about could qualify for legal action, along with their loved ones.

If you or a loved one suffered Xarelto bleeding or other side effects, consider talking to the attorneys at McDonald Worley to evaluate your legal options.