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Federal drug regulators are finally going to allow large-scale production of Andexxa, a reversal agent designed to stop potentially deadly bleeding problems from Xarelto and Eliquis, after restricting the antidote to a limited production schedule for months.
Portola Pharmaceuticals issued a press release last week, announcing that the FDA has granted permission for large-scale, commercial sales of Andexxa throughout the United States. Following several months of limited production, company officials say the agency saw the need for large-scale production to prevent Xarelto (rivaroxaban) and Eliquis (apixaban) bleeding injuries and deaths.
The FDA approved Andexxa for limited release to only 40 to 50 hospitals in May 2018, as an antidote for Factor Xa blood thinner effects. It is designed to allow doctors to reverse uncontrollable bleeding problems linked to the new generation of anticoagulants.
“It is clear from the response to the Andexxa Early Supply Program that there is significant need for a specific reversal agent that can address life-threatening bleeding associated with the use of the Factor Xa inhibitors apixaban and rivaroxaban,” Scott Garland, Portola’s president and chief executive officer, said in the press release. “We are pleased to now be able to stock hospitals nationwide and serve all patients in the U.S. who could benefit from the potential life-saving impact of Andexxa.”
Portolo indicates that there has been an increase of hospital admissions and deaths linked to Xarelto and Eliquis bleeding events, noting that in 2017, there were about 140,000 hospital admissions linked to the use of Factor Xa blood thinners.
Xarelto and Eliquis were introduced as a new-generation replacements for warfarin, as a preventative treatment for strokes and other problems associated with atrial fibrillation. However, the two drugs have been linked to thousands of reports involving severe and fatal injuries, when users experienced bleeding that doctors were unable to stop or reverse.
Unlike warfarin, which can be quickly reversed with a known antidote, no approved reversal agent for Xarelto had been available since the drug was introduced in 2011, until the development of Andexxa.
FDA officials have been cautious about the reversal agent, which may be used by millions of patients, and called for more evidence that it is safe and effective. In addition, a 2016 study showing positive results for AndexXa (andexanet alfa) has come under scrutiny by doctors, who say that the study’s researchers may have been overstating its benefits.
Incidents of unstoppable bleeding have resulted in injury and death for patients using the new drugs. Currently, there are about 20,000 Xarelto lawsuits pending as part of a federal multidistrict litigation (MDL), which is centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana.
Each of the claims raise similar allegations that users and the medical community were not adequately warned about the risk of uncontrollable bleeding on Xarelto.
Following a handful of early bellwether trials, which were held before Judge Fallon to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation, no progress has been made in negotiating Xarelto settlements or another resolution for the claims.