Three lawsuits filed in New York state court on May 22, 2017, allege that Bristol-Myers Squibb and Pfizer created a defective blood thinner-Eliquis-that can cause serious bleeding events.
According to Law360, the lawsuits claim the drug makers misrepresented the safety of the Eliquis, hiding their knowledge of the bleeding risks and the lack of an antidote for patients who begin to bleed after taking the drug.
The legal complaint says the drug makers “concealed and failed to completely disclose their knowledge that Eliquis was associated with or could cause life-threatening bleeding in specific patient populations, and failed to fully identify and convey the risks of use of Eliquis at the same time as other blood-thinning agents, such as aspirin.”
The U.S. Food and Drug Administration (FDA) approved Eliquis (apixaban) in 2012, largely based on the ARISTOTLE clinical trial (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation). But plaintiffs allege that trial was a conducted by “incompetent and untrustworthy” parties in China. Bristol-Myers and Pfizer allegedly hid side effects, and did not report a death or the loss of subjects, or drug dispensing errors, according to Law360. The lawsuits allege poor quality control and falsified records throughout the trial.
The drug-injury attorneys at Parker Waichman LLP note the growing number of lawsuits alleging that blood thinners like Eliquis, Xarelto, and Pradaxa have caused serious bleeding episodes.
Warfarin (Coumadin) has been the standard blood-thinning drug for 60 years for people at risk for blood clots. But people taking warfarin must undergo regular blood tests to ensure that they have the proper amount of the drug in the bloodstream. With too little of the drug, the user remains at risk for blood clots. With too much, the person is in danger of uncontrolled bleeding. Patients must also follow a careful diet to avoid interactions that will diminish warfarin’s effectiveness.
Eliquis is prescribed to help prevent strokes in patients with atrial fibrillation (a common heart rhythm problem that causes blood clots to form in the heart). Atrial fibrillation is associated with a high risk of stroke. Eliquis helps prevent deep vein thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and become lodged in the blood vessels, causing pulmonary embolism. A blood thinner is often prescribed for a patient during recovery from hip or knee replacement surgery when the patient is at risk for blood clots.
Blood thinners improve blood circulation by inhibiting the clotting mechanism. But reduced clotting ability creates the risk of bleeding that is difficult to control. Without proper blood clotting ability, the patient could experience a serious or even fatal bleeding episode. If an Eliquis user is injured or needs emergency surgery, reduced blood clotting ability puts the patient at risk for uncontrolled bleeding.
Eliquis Adverse Effects
People taking Eliquis have reported:
- uncontrolled bleeding
- gastrointestinal bleeding
- hemorrhagic stroke (brain bleed)
- intracranial hemorrhage (bleeding in the skull)
- kidney bleeding
- rectal bleeding
- unusually heavy menstrual bleeding
- blood clot
- deep vein thrombosis
The highly promoted ease and convenience of the new generation blood thinners Eliquis, Pradaxa, and Xarelto has been called into question. Plaintiffs in Xarelto lawsuits say the dosing does not take into account differences in weight and size. Larger and heavier people may not be getting adequate protection from the standard dose, leaving them at risk for stroke despite the fact that they are taking a blood thinner. And certain populations, like the elderly, may need some blood testing to monitor the drug level.
When Eliquis came to market five years ago, the label did not disclose the lack of a reversal agent (antidote). But despite this deficiency, Bristol-Myers Squibb and Pfizer embarked on an “aggressive marketing campaign” to capture a large share of the blood thinner market. The drug makers stressed the convenience of Eliquis. Unlike warfarin, Eliquis does not require regular blood testing or a restrictive diet. All patients could take a set daily dose of Eliquis. But warfarin has one safeguard that Eliquis lacks: warfarin has a readily available antidote that can help restore the blood’s clotting ability.
The legal complaint says that in direct advertising to consumers, Pfizer and Bristol-Myers Squibb “overstated” the efficacy of Eliquis in preventing strokes and embolisms while failing to adequately warn that there is no reversal agent. This could have “life-threatening and fatal consequences.”
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