An FDA reviewer is questioning claims that Eliquis reduces deaths in patients with atrial fibrillation, alleging that the data provided regarding Eliquis side effects may not be accurate.

According to Eliquis clinical trials, patients receiving the blood thinner drug were 11 percent less likely to die from any cause than those on warfarin, which had been the staple drug used for decades to prevent strokes in people with atrial fibrillation.

Dr. Thomas Marciniak, who works at the FDA as a medical team leader, claims that when Bristol-Myers Squibb and Pfizer submitted clinical trial data on Eliquis side effects, some critical safety information had completely vanished. In fact, data on around 300 patients who participated in the trial had gone missing.

“Perhaps some (patient data) were lost to follow-up because they had a stroke or died, which potentially biases the study results,” they wrote. “However, there is no reason to believe that this was more likely in the apixaban (Eliquis) arm than in the warfarin arm. We cannot directly address whether the missing data are biased in one direction.”

Marciniak claims that if there had been just one more death among Eliquis patients — or one less death in the warfarin group they were being tested against — the drug would not have been able to demonstrate any statistical benefit and there would have been no reason for the FDA to approve Eliquis.

“I, like most FDA reviewers, would like to conclude that apixaban (Eliquis) is effective in atrial fibrillation — we would like to have alternatives to warfarin,” Marciniak stated. But the data quality “destroy our confidence” that the drug reduces deaths, he wrote.

Pfizer and Bristol-Myers Squibb, co-marketers of the drug, stand by their clinical data, stating “The data was “thorough and complete, despite inherent challenges with following such a large and diverse population…As the FDA ultimately decided, the small fraction of patients lost to follow-up did not adversely alter the interpretation of superior results vs. warfarin.”

What is Eliquis?

Eliquis (apixaban) was approved in 2012 to help prevent blood clots that may cause strokes in patients who have atrial fibrillation. The FDA later approved the drug to help prevent deep vein thrombosis and pulmonary embolism.

Made by Pfizer and Bristol-Myers Squibb, Eliquis is one of a new generation of anticoagulants called direct thrombin inhibitors. Like the other new anticoagulants Xarelto and Pradaxa, Eliquis has been aggressively marketed as a superior alternative to warfarin (Coumadin), an older blood thinner, because the newer medications require less patient monitoring.

Eliquis Bleeding Risk

Several Eliquis side effects have recently come to light, including increased bleeding and bruising. One of the real dangers of using Eliquis is that it does not have a reversal agent to stop its blood-thinning effects during a bleeding event. As a result, it is believed that Eliquis side effects may put patients at risk for serious, irreversible internal bleeding.

Unlike the older anticoagulant warfarin, the effects of which can be reversed with common treatments such as Vitamin K, the maker of Eliquis has yet to develop an antidote to reverse Eliquis side effects.

The Problem With Blood Thinner Medications

Blood thinner medications, like Eliquis, are often prescribed to people who have a high risk of developing blood clots that could prevent the free flow of blood through arteries, potentially causing a stroke. Blood clots can also lead to other serious health conditions, including deep vein thrombosis (clotting that causes swelling in the legs and thighs), pulmonary bleeding, and gastrointestinal bleeding.

While anticoagulants like Eliquis are vital to the health of many patients, their use may come with bleeding risks. The possibility that the drug will cause internal bleeding is one of the most serious concerns.

For years, Warfarin has been the most frequently prescribed blood thinner. However, the correct dosage of Warfarin is difficult to control and an incorrect dosage can cause internal bleeding and other health problems. Fortunately, an antidote to Warfarin is available that can be administered to patients who experience internal bleeding as a result of using the drug.

Eliquis Side Effects Lawsuits

In Eliquis lawsuits, multiple injured patients and grieving loved ones are now claiming that the drug’s makers did not provide sufficient information about the risk of Eliquis side effects like internal bleeding or the lack of an antidote.