Eliquis (apixaban) is a part of a new generation of oral anticoagulants introduced in recent years as a replacement for warfarin. However, side effects of Eliquis have been linked to reports of severe and uncontrollable bleeds, hemorrhages and wrongful death.
Initially approved for prevention of strokes and blood clots among individuals with non-valvular atrial fibrillation, Eliquis was later approved for use in preventing blood clots following hip or knee replacement, as well as for treatment of deep vein thrombosis and pulmonary embolism. It is a direct competitor to Xarelto and Pradaxa, which have also been linked to reports of serious bleeding problems and thousands of lawsuits filed by individuals nationwide.
The product liability lawyers at Saiontz & Kirk, P.A. are reviewing potential cases against Bristol-Myers Squibb and Pfizer, Inc. for failing to warn about the potential Eliquis side effects, including:
- Increased Risk of Bleeding
- Lack of Reversal Agent to Allow Doctors to Stop Bleeds
- Failure to Provide Warnings About Importance of Monitoring
If information about the potential Eliquis risks had been provided to consumers and the medical community, individuals nationwide may have avoided severe and sometimes fatal injuries while using the drug. As a result, financial compensation may be available.
To review a potential case for yourself, a friend or family member, request a free Eliquis lawsuit evaluation.
Eliquis Bleeding Risks
Eliquis is a member of a class of drugs known as Factor Xa inhibitors. The drug was jointly developed by Bristol-Myers Squibb and Pfizer, Inc. and is approaching blockbuster status, amid aggressive marketing designed to encourage doctors to use the new medication, instead of warfarin.
Since it was introduced in 2012, an increasing number of Americans have been prescribed Eliquis to reduce the risk of stroke and blood clots associated with non-valvular atrial fibrillation, to treat deep vein thrombosis (DVT), to treat pulmonary embolism (PE) and to reduce the risk of DVT and PE following knee or hip replacement surgery.
The medication works by inhibiting the enzyme in the blood that causes clotting. However, with no approved antidote available to quickly reverse the blood thinning effects of Eliquis, doctors are often left unable to stop or control hemorrhages or bleeding that may develop among users.
Eliquis has been marketed as easier to use than Coumadin (warfarin), indicating that less blood monitoring is required. However, important safety information and warnings were withheld.
Post-marketing reports indicate that users face a serious risk of gastrointestinal bleeding, hemorrhages and other problems that may have been avoided if warnings about the side effects of Eliquis had been provided by the drug makers.
Eliquis Clinical Trials
Eliquis was approved using the results of an industry-sponsored clinical trial known as ARISTOTLE, which claimed in findings presented to the FDA that the drug was safe and effective when compared to warfarin. However, numerous questions have been raised over the validity of the ARISTOTLE clinical trials.
Before Eliquis was introduced, FDA reviewers warned that there was missing data from the study, which was conducted in part in China. The FDA found a pattern of inadequate supervision throughout the clinical trials, and the former editor in chief of the New England Journal of Medicine held the clinical trial up as an example of bad science being conducted by the pharmaceutical industry, noting that the study actually failed to show that Eliquis was any more effective than the cheaper and proven warfarin.
FDA investigators found poor quality control, changed and falsified data, at least one unreported death in a study whose purpose was to compare death rates, and some records reportedly disappeared just before the FDA came to inspect a site, allegedly on the orders of a Bristol-Myers Squibb employee.
Despite these shortcomings, the FDA approved Eliquis anyway.
Even after the link between Eliquis and bleeding problems became evident in post-marketing adverse event reports, the drug makers continued to promote the medication as safe and effective, withholding information on the risk of irreversible bleeding.
Rather than taking steps to issue an Eliquis recall, provide stronger warnings or develop an effective antidote to reverse the blood thinning side effects of the drug, marketing continued and the pharmaceutical companies have pushed for expanded use of Eliquis.
Cases for Eliquis Hemorrhages and Bleeding Side Effects
As a result of the drug makers’ apparent decision to place their desire for profits before consumer safety, financial compensation and Eliquis settlements may be available for individuals and families who have experienced:
- Internal or Gastrointestinal Bleeds
- Brain Hemorrhage
- Hemorrhagic Stroke
- Wrongful Death
The Eliquis side effects lawyers at Saiontz & Kirk, P.A. are reviewing potential cases for individuals throughout the United States. All lawsuits are handled on a contingency fee basis, meaning there are no out-of-pocket expenses to hire our law firm, and attorney fees are only received if we are successful in obtaining a recovery for our clients.
