Last month DrugNews reported that the FDA had delayed approval of an antidote for new age blood thinning drugs Eliquis and Xarelto due to questions with the manufacturing process.
Now, as the number of patients injured or killed by uncontrollable internal bleeding continues to rise, new data suggests the experimental antidote could help save as many as 90% of them from the risk.
The Growing Use of Blood Thinners
Along with their competitor Pradaxa, the new generation anticoagulants Eliquis and Xarelto are prescribed more than 6 million times each year in the United States. They’ve created a new class of drugs to replace the decades-old warfarin, which had dietary restrictions and the need for constant blood testing.
And, where these drugs were once only intended for heart patients with atrial fibrillation, they are now prescribed to millions of others to prevent repeat blood clots or protect against stroke after certain surgeries.
The Growing Bleeding Risks of Anticoagulants
As the use of these newer blood thinners grows, so does the number of patients hospitalized or killed by internal bleeding. That’s due in part to the fact that they don’t come with an antidote like warfarin does.
So far, more than 15,000 hospitalizations and 2,500 patient deaths have been linked to Xarelto, Eliquis or Pradaxa since they first hit the market in 2010.
Also, more than 10,000 lawsuits have been filed in federal courts over these bleeding injuries, with hundreds of millions of dollars being paid to victims.
New Antidote Could Help Thousands
Now, new data released at last month’s annual European Society of Cardiology meeting in Rome shows most of the internal bleeding injuries of Xarelto or Eliquis could be prevented.
Portola Pharmaceuticals, who is currently seeking FDA approval for its Factor Xa bleeding antidote AndexXa, released interim data of an ongoing study that showed promising results.
The drug caused an 89% reduction in the blood-thinning effects of Xarelto, and a 93% decrease in the effects of Eliquis. Overall, 79% of patients experienced an “excellent” or “good” stop in internal bleeding within 12 hours of being given AndexXa.
While these results show thousands of patients could be saved from injury or death, the antidote could be months or years away from approval due to FDA delays. And, since the makers of Eliquis and Xarelto didn’t fully warn patients of the risks, more people continue to be affected each day.
Check back with DrugNews for the latest research and safety news for anticoagulant and other drugs.
Helfand, C. Portola touts new data on recently rejected Xarelto, Eliquis antidote FiercePharma. (August 30, 2016). Retrieved from www.fiercepharma.com
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