FDA Reviews Eliquis Data and Finds Safety Problems As More Lawsuits are Filed
For the last few years, Bristol-Myers Squibb and Pfizer have pushed their joint anticoagulant, Eliquis, as safer than many other anticoagulants out on the market, including Pradaxa, Coumadin/warfarin, and Xarelto – all of which face personal injury and wrongful death lawsuits. Many patients suffered or died because they took the anticoagulant, and their stories are similar to the Pradaxa and Xarelto plaintiffs.
One of the most recent lawsuit filings comes from plaintiff Deborah Herschell, who filed a wrongful death lawsuit against Eliquis on June 15th this year. Her husband, Donald, died from irreversible internal bleeding just three months after he began taking Eliquis to prevent blood clots or strokes due to his arterial fibrillation. His prescription was filled first in August 2014; he died of a gastrointestinal bleed on October 21st, 2014.
Eliquis is in the same family of anticoagulants as Pradaxa and Xarelto – Factor Xa inhibitors, mainly in the generic drug apixaban. They rapidly enter the bloodstream and, like Coumadin/warfarin, break up blood clots. Generic warfarin and its brand name Coumadin, however, require patients to undergo constant monitoring for high or low levels and constant adjustments to continue to prevent blood clots without causing internal bleeding. Apixaban drugs do not require such monitoring, but in part, that is because they cannot be monitored.
Worse, none of the Factor Xa inhibitors have antidotes in the event that a patient develops internal bleeding.
While patients on warfarin are constantly monitored, which can cause an inconvenience for the patient, the drug can be reversed with an injection of vitamin K. There are no simple solutions or reversals for bleed-outs with apixaban drugs, including Eliquis. None of the drug companies that manufacture these anticoagulants mentions that in their marketing.
Because of the high number of deaths and personal injury lawsuits associated with Eliquis, the FDA has started a review of the safety trial data – and found something startling. While the trial data suggested that patients on Eliquis were 11% less likely to die from internal bleeding problems than warfarin patients, one FDA reviewer found, as early as December 2012, that 300 Eliquis patients had missing data.
Thomas Marciniak, the reviewer in question, sent a memo to FDA officials in 2012 that he’d found missing data in the Eliquis safety review. “I, like most FDA reviewers, would like to conclude that apixaban (Eliquis) is effective in atrial fibrillation — we would like to have alternatives to warfarin,” Marciniak wrote. But the data reporting problems “destroy our confidence.”
The FDA responded, however, that the missing data was not considered large enough to be worried. “Perhaps some (patient data) were lost to follow-up because they had a stroke or died, which potentially biases the study results,” they wrote. “However, there is no reason to believe that this was more likely in the apixaban (Eliquis) arm than in the warfarin arm. We cannot directly address whether the missing data are biased in one direction.”
Herschell’s lawsuit, however, points out that there was considerable fraud continuing through the FDA review and the ARISTOTLE study, which looked at the overall efficacy of apixaban drugs. “Instead of admitting the major errors and frauds involved in the ARISTOTLE study, defendants misleadingly stated publically that they were submitting ‘additional data’ to the FDA, and to this date have never publically acknowledged the missing and incorrect data submitted to the FDA, which would be of concern to prescribing physicians and the public,” her wrongful death lawsuit claims.