![]() ![]() Reports of patients who were given the wrong medication or the wrong dosage.Failure to report adverse events (including deaths).According to the FDA, problems with ARISTOTLE included: The trial in question is known as ARISTOTLE (Apixaban for Reduction in Stroke and Other Thrombotic Events in Atrial Fibrillation). The agency said that the mistakes demonstrated a “pattern of inadequate trial conduct and oversight.” ![]() FDA delayed approval of Eliquis for 9 months over misconduct, errors, and an alleged cover-up at a clinical trial site in China. Lawsuits allege that clinical trials used to support Eliquis’ approval were deeply flawed, which led patients to use a harmful drug that should not have been on the market in the first place. Additionally, clinical trials used to approve Eliquis have been heavily criticized for containing inaccurate and missing data, reports of patients receiving incorrect doses of medication, and omitting adverse events including death. What’s the Problem?Įliquis has recently been linked to reports of uncontrollable bleeding events including bleeding in the brain (cerebral hemorrhage), intestinal bleeding (GI bleed), kidney bleeding and deep vein thrombosis (DVT). Food & Drug Administration (FDA) in December 2012. Eliquis was developed in a joint partnership between Pfizer and Bristol-Myers Squibb, and was approved by the U.S. The drug works by blocking Factor Xa, which is a blood-clotting factor critical to the blood-clotting process. Eliquis (generic: apixaban) is a blood-thinner medication that stops blood from clotting and reduces the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (a-fib). ![]()
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