Falsified trial data leads to unnoted side effects of popular anticoagulant, Eliquis
Eliquis (apixaban) is an anticoagulant (blood thinner) used to reduce the risk of blood clots and stroke. Doctors prescribe the oral medication in one dose. Unlike older anticoagulants like Xarelto and Pradaxa, Eliquis requires required patient-specific dosages and patient monitoring. Bristol-Myers Squibb and Pfizer developed the drug and marketed it as a safer alternative to other blood thinners.
Eliquis was the last blood thinner to receive FDA approval in 2012 for only three uses:
- Reducing the risk of systemic embolisms (life-threatening blood clots) and strokes in patients with non-valvular atrial fibrillation (irregular heartbeats)
- Lowering the risk of deep vein thrombosis (DVT), which are blood clots that form in the legs, and pulmonary embolisms (PEs), which are blood clots in the lungs especially following hip or knee replacement surgery
- Treating DVT and PEs and reduce the risk of reoccurrence
Approval for Eliquis hinged on a trial called ARISTOTLE (Apixaban for Reduction in Stroke and Other Thrombotic Events in Atrial Fibrillation). The trial spanned over 1,000 locations and 40 different countries. This included 36 sites and 18,000 patients in Asia. Independent researchers uncovered 18 of these Asian sites had altered records to cover up numerous violations of good clinical practice guidelines. This could mean a whole host of troubling misconduct such as wrongful selection of subjects, not monitoring procedures and even not reporting adverse drug reactions.
Additionally, there were data discrepancies. Patient names and dates did not match. English and Chinese data reports showed completely different numbers. Even entire reports disappeared. The FDA did step in to investigate but determined that the Asian sites didn’t change the trial results.
The discrepancies in the Asian sites weren’t the only flaw in the ARTISTOLE trial. A large number of participants in the trials conducted all over the world received incorrect medications and even the wrong dosages. Some received a double dose or none at all. In fact, this changed the entire outcome of the results.
An appalling fact is that neither manufacturer believed the ARISTOTLE trial cover up, the missing data nor the inaccurate distribution of medicine to patients affected the trial’s integrity.
A Bristol-Myers Squibb representative said the mistakes made during the trials were “not exceptional issues,” and had “no impact on the integrity of the study results or conclusion of the study.”
A spokesperson for Pfizer was reported as saying the company was confident in the results of the clinical trials.
Eliquis, like other newer generation oral anticoagulants (OACs) like Pradaxa and Xarelto, have been linked to an increased risk of uncontrolled bleeding (hemorrhaging). This is because the drug prevents stroke by inhibiting the blood clotting mechanism.
Warfarin, an older anticoagulant in use for over 50 years in the U.S., also prevents blood from clotting. However, doctors can reverse warfarin with a single dose of vitamin K. No such antidote exists with Eliquis, so once a bleeding event starts, it is nearly impossible to stop.
In an August 2014 study published in the Journal of Neurosurgery, the authors concluded that “Despite their convenience, efficacy and lower (brain bleed) risk, a major limitation of the targeted OACs is that there is currently no specific antidote for any of the agents.”
Many consumers feel that Bristol-Myers Squibb and Pfizer did not adequately warn about Eliquis’ side effects. Additionally, the FDA should have never approved the drug from a flawed study.
Eliquis Patients & Blood Tests
Patients taking warfarin typically need their blood tested between once a week and once a month. However, those using Eliquis and other newer-generation anticoagulants don’t require intensive monitoring.
Warfarin works by making the blood less likely to clot by blocking the body’s ability to recycle vitamin K, which it uses to form clots. With less vitamin K circulating, blood takes longer to clot, but patients require regular testing to ensure proper dosage. Since Eliquis and other new blood thinners do not affect vitamin K, patients do not need constant monitoring.
Conversely, Eliquis is much more expensive. Treatment with warfarin costs only about $4 per month, however, a typical monthly dose of Eliquis costs around $300. This is a steep price to pay especially with internal bleeding risks.
Experts expect lawsuits to rise since Eliquis remains on the market amidst claims that it is not as safe as its manufacturers suggest. In July 2015, Deborah Herschell filed the first Eliquis lawsuit in the Southern District of New York. Her husband, Donald Herschell, died from gastrointestinal and brain hemorrhages while taking Eliquis. The lawsuit claims Bristol-Myers Squibb and Pfizer concealed knowledge of Eliquis’ defects from the Mr. and Mrs. Herschell and their doctor.
The manufacturers of Eliquis (Bristol-Myers Squibb and Pfizer) are no strangers to pharmaceutical lawsuits.
In 2001, Bristol-Myers Squibb participated in an illegal business practice called channel stuffing. This caused a U.S. Securities and Exchange Commission investigation who filed fraud charges. Channel stuffing is a tactic in which companies inflate their sales numbers by sending businesses more products than they can sell. The company settled for $839 million.
In 2002, Pfizer settled charges for illegally marketing a drug called Bextra for $2.3 billion. During the following decade, it settled separate lawsuits involving its drugs Lipitor, Neurontin, and Detrol for a combined total of more than $490 million.
In 2007, Bristol-Myers settled illegal marketing and pricing charges for $515 million after overcharging the government for drugs and illegally promoting the antipsychotic Abilify.
Thousands have already filed lawsuits against the manufacturers of Xarelto and Pradaxa. Boehringer Ingelheim settled more than 4,000 lawsuits for $650 million after uncovered a high rate of heart attacks and uncontrollable bleeding in Pradaxa users. More than 500 people have filed lawsuits claiming Xarelto caused irreversible bleeding to them or their loved ones.
We Want to Help Victims
It is your right to be informed about the long-term risks associated with the medications you take, and it is the responsibility of drug companies to provide this information. If you or a loved one has developed uncontrollable bleeding after taking Eliquis, you should demand accountability from Bristol-Myers Squibb. Why weren’t you told?
We want to help send a message that this is not acceptable. Also, we are advocates for consumers who have been harmed by dangerous products, and we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. Compensation for injuries and damages could be available.
The recoverable losses include:
- Past and future medical expenses
- Lost wages
- Loss of an ability to work; and
- Pain and suffering
If a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
If the conduct of a drug company in manufacturing and selling drug is found to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future. If you developed a compulsive behavior after taking Eliquis, please speak to us to learn more about your rights.