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FDA Reviewer Questions Claims Made by Eliquis Maker

The manufacturer of Eliquis is now claiming there has been a reduction in deaths for Afib patients who take the anticoagulant medication, but a review at the United States Food and Drug Administration is questioning this allegation, according to a recent news article from the Journal Sentinel.

pillsEliquis is one of what are now four new anticoagulants on the market to treat a medical condition known as atrial fibrillation (Afib). Afib is characterized as a disease associated with an irregular heartbeat that leads to the formation of blood clots, and, if these clots end up blocking blood to the brain, they can cause the patient to have a stroke. For this reason, the patient must take either a blood thinner, which was the preferred form of therapy for years, or one of the new oral anticoagulants (NOACs), including Xarelto, Eliquis, Pradaxa and Savaysa.

That last one, Savaysa, just received FDA approval and was brought to market earlier this year.

As our Boston Eliquis injury attorneys can explain, these drugs can lead to a serious internal bleeding condition that has been shown to result in serious injury or death. One of the reasons the side effect is so devastating is because there is no FDA-approved cure or “reversal agent,” and doctors are often left helpless while a patient dies in the emergency room.

While each maker of these four drugs claims their respective product is a safe and effective treatment for Afib and does not require constant monitoring of a patient’s blood or dietary restrictions, only the makers of Eliquis are claiming its drug has been shown to actually lower the death rate for Afib patients. The drug company is trying to get the medication approved for other uses, so they are submitting information such as this to the FDA; however, in this case, at least one FDA reviewer is questioning the validity of these claims Eliquis can reduce the death rate in Afib patients.

As part of a clinical trial involving Eliquis, the company reported patients taking their NOAC were 11 percent less likely to die from any medical condition than patients who were taking Warfarin, which is the traditional treatment for Afib. While this sounds like a strong claim, and FDA reviewer questioned the trial, because vital data about deaths was not included in the trial, and questioned whether the results were statistically significant, noting that, if one more patient on Eliquis died, the numbers would not be very impressive.

Apparently, there were over 300 patients in the study taking Eliquis, and data about whether they lived or died was not included in the study. With such a large gap in the data, the reviewer was skeptical that the claims of an 11 percent reduction would be accurate or have any statistical importance. Somewhat ironically, one of the reasons they might not have had vital information for all patients is because, if those patients died, they would not be able to get follow-up information as easily, and with it being common for patients in a study to drop out, they often just write these patients off as failing to complete. The problem seems to be that they included theses patients in the death rate calculation.

If you are the victim of a Massachusetts drug injury due to taking Eliquis, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.

Additional Resources:

Eliquis claim about reduced deaths questioned by FDA reviewer, August 14, 2015, Journal Sentinel, by John Fauber and Coulter Jones

More Blog Entries:

Risk for Internal Bleeding after Taking Pradaxa, August 22, 2014, Boston Dangerous Drugs Injury Lawyer Blog