An FDA reviewer is questioning claims made by Bristol-Myers Squibb suggesting that its anticoagulant drug Eliquis reduces deaths in patients with atrial fibrillation, according to a watchdog report published in the Journal Sentinel.
Free Confidential Lawsuit Evaluation: If you or a loved one suffered bleeding or other side effects from Eliquis, you should contact our law firm immediately. You may be entitled to compensation by filing a class action suit our lawyers can help.
What’s the Problem?
Bristol-Myers Squibbs claims Eliquis (generic: apixaban) reduces deaths in patients with a-fib. The company supports this claim by citing a clinical trial that found patients treated with the drug were 11% less likely to die from any cause compared to those who took warfarin.
However, FDA reviewer Thomas Marciniak says that key data on more than 300 Eliquis users was missing from the trial, and that one more death among patients treated with the drug or one less death in warfarin users would mean the benefit was no longer statistically significant.
“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 in a 2012 memo. But the data problems “destroy our confidence” that Eliquis reduces death, he concluded.
Marciniak called for information about the data problems to be included on the drug’s labeling, but he was denied by others at the FDA. In a response to the memo, 2 other FDA officials said that Marciniak’s comments were “somewhat unrealistic,” and that the missing data wasn’t “especially large.”
However, F. Perry Wilson, an expert in clinical trial design and an assistant professor of medicine at Yale, said Marciniak makes a valid argument.
“I would tend to agree that touting this as a potential (mortality) benefit of the drug is likely very premature,” said Wilson, who reviewed FDA documents for this report.
Do I Have an Eliquis Class Action Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Eliquis lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one was injured by the side effects of Eliquis, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.