Eliquis

The Truth

Eliquis, also known as apixaban, is a pharmaceutical anticoagulant. Manufactured by Bristol-Myers Squibb and Pfizer, Eliquis is one of the newest blood thinners leading the market. The once-daily pill is touted as a simpler, easier way to manage blood clots and prevent stroke.

Eliquis is comparable to Xarelto and Pradaxa, two new-age competitors. Although these drugs require less intensive monitoring from health professionals, no antidote exists for the Eliquis bleeding side effect.

The truth is that the drug almost wasn’t approved after an alleged cover-up of misconduct in the clinical trial and flawed conclusions. Today, the drug now garners millions for Big Pharma.

Studies + Science

How does Eliquis work?

Like other blood thinners in its class, Eliquis works by blocking a chemical called Factor Xa. The drug stops the formation of thrombin, the protein that causes clotting in the blood.

New-age blood thinners came to the market in an attempt to oust long-standing blood thinner Warfarin, which require additional testing and attention from doctors. Although Warfarin treatment must be closely monitored, vitamin K can be used as an antidote for Warfarin bleeding side effects.

Eliquis Bleeding Side Effect

The side effects of Eliquis can be life-threatening. Eliquis bleeding, which can be internal or cause hemorrhage, is impossible to control without a reversal agent. People taking Eliquis are at risk of bleeding to death.

Eliquis can also cause skin rashes and increased frequency of bruising. In the trial that led to the approval of Eliquis, it was clear that something wasn’t right.

The ARISTOTLE Study

Eliquis was approved after a clinical trial took place in more than 40 different countries. Scientists from more than 1,000 locations gathered data, with a majority of the information coming from China. The study included 18,000 patients in Asia.

The trial, called ARISTOTLE (Apixaban for Reduction in Stroke and Other Thrombotic Events in Atrial Fibrillation), measured the drug’s safety and effectiveness as compared to other existing blood thinners.

Published in the New England Journal of Medicine, the results were subject to a long list of objections. The concerns were so extensive that they threatened FDA approval. The data had to be reanalyzed due to a “pattern of inadequate trial conduct and oversight,” according to the FDA.

The issue stems from one Chinese employee who dealt with data in 19 locations. The employee, who has since been dismissed from the company, doctored records to hide violations of proper clinical practices. The employee failed to report four adverse events, submitted a late report of three adverse events, and did not include three findings within the conclusions.

The results show many patients weren’t given the correct dosage of Eliquis, putting them and the study at risk. Some patients took extra doses while others received none of the substance at all.

Because the data came from China, there were translational inconsistencies and issues with names and dates. After questioning the data at 24 different Chinese trial locations, the FDA decided that the trial errors did not significantly alter the data results.

Regulation Rewind

The FDA’s internal disagreement about Eliquis approval was centered around a cover-up attempt, alleging the trial included improper distribution of medication and unreported adverse events.

Arnold Relman, the former editor of the New England Journal of Medicine, objected to the publication of the study, citing monetary motivations. Regardless of the complaints, the ARISTOTLE trial was published in the New England Journal of Medicine.

After nine months of debate, the U.S. Food and Drug Administration (FDA) allowed Eliquis to enter the market in December 2012. Although some FDA members voiced clear concerns about the effectiveness of Eliquis, the blood thinner was approved to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation.

In March 2014, the agency approved the drug to reduce the risk of blood clots after knee or hip replacement surgery. In August 2016, the FDA added DVT and pulmonary embolism to the list.

Bristol-Myers Squibb and Pfizer have attempted to make Eliquis a standout drug, working to elevate it as a better option than other blood thinners. The pharmaceutical company attempted to urge the FDA to add a significant reduction in mortality to the Eliquis label, which would put it above Xarelto and Pradaxa. Despite the push from manufacturers, the data was insignificant to prove this factor.

In June 2017, Bristol-Myers Squibb voluntarily recalled a lot of Eliquis for allegedly containing improper dosages. According to the recall, the lot of 5mg Eliquis tablets actually contained only 2.5mg of the drug.  The FDA stated that the recall would only affect distributors and that none of the mislabeled products had made their way into any consumer homes.

Despite Eliquis’ controversy, in Dec. 2019, the FDA approved generic versions of Eliquis to be distributed and sold. The generic Apixaban tablets were approved for “the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism” from two applicant manufacturers.

Regardless of the incomplete data, flawed results and alleged cover-up drug manufacturers have been making high profits off Eliquis. In 2014, Eliquis brought in $774 million in profit for the drug companies.

The Next Steps

The drug manufacturers assert the integrity of the studies that led to the approval of Eliquis, but many people are experiencing extreme bleeding every day. Though some patients might be better suited to take the antidote-possessing drug Warfarin, Bristol-Myers Squibb and Pfizer continue to push Eliquis.