Eliquis, a popular blood thinner, is prescribed to patients to reduce the risk of strokes and systemic embolism in patients with nonvalvular atrial fibrillation.

However, it is not without side effects. Reports of Eliquis side effects have plagued the FDA as adverse event reports regarding excessive bleeding associated with Eliquis have come in.

Eliquis is often prescribed to prevent systemic embolism. In a systemic embolism, an “embolus,” or a form of blood clot, is formed in a systemic vein which adversely impacts the lungs after passing through the right side of a patient’s heart.

Once the embolus passes through, a pulmonary embolism may form causing a blockage of the main artery of the lung.

Non-valvular atrial fibrillation is the most common type of heart rhythm abnormality. The causes for patients who suffer from atrial fibrillation are many including valvular heart disease.

In patients, however, who have an irregular heart rhythm and the abnormality is not caused by valvular heart disease, the term used for the diagnosis is non-valvular atrial fibrillation.

Recall Addresses 2.5mg Eliquis Tablets in 5mg Package

The FDA announced in June of this year that Bristol-Meyers Squibb is recalling one lot of Eliquis tablets packaged as containing a 5mg dose, after one patient reported finding tablets that contained only 2.5mg. The affected lot was distributed in February 2017.

According to the FDA, 5mg tablets of Eliquis are pink in color and marked on one side with the number “5” and on the other side with the number “894.” The 2.5mg tablets are yellow, with the numbers “2 1/2” and “893” stamped on their sides.

The FDA reminds patients not to stop taking Eliquis without first consulting their doctor. Patients who believe they are experiencing problems related to Eliquis are encouraged to consult their physicians.

According to the U.S. Food and Drug Administration, recommended doses prescribed to most patients for treatment of these risks is 5 mg taken orally twice a day. The FDA also notes there is an increased risk of stroke with discontinuation of Eliquis and other Eliquis side effects when taking the medication.

Eliquis side effects include and are not limited to the following: blood in the eyes, blood in the urine, bruising or purple areas on the skin, dizziness, fainting, fast heartbeat, joint pain or swelling, nosebleeds, severe stomach pain, shortness of breath and vomiting of blood or material that looks like coffee grounds.

The FDA maintains that discontinuing Eliquis without adequately providing an anticoagulant alternative increases the risk of thrombotic events. The FDA states that, “an increased rate of stroke was observed during the transition from Eliquis to warfarin [another commonly used anticoagulant] in clinical trials in patients with nonvalvular atrial fibrillation.”

Eliquis side effects are numerous. Eliquis, particularly, is claimed to increase the risk of bleeding and can cause potentially fatal and serious bleeding events. According to the FDA, “the most serious adverse reactions reported with Eliquis were related to bleeding.”

Other Eliquis side effects include anemia, hemorrhage and nausea.

Eliquis Side Effects Clinical Trials Conclusions

The U.S. Food and Drug Administration asserts that the safety of Eliquis was evaluated and assessed in the ARISTOTLE studies and AVERROES Studies.

These studies included a sample size of 11,284 patients who were exposed to Eliquis 5 mg twice a day, and included 602 patients who were exposed to Eliquis 2.5 mg twice a day. In the ARISTOTLE study, the duration of exposure was 89 weeks, while the AVERROES study included an exposure time of roughly 59 weeks.

According to both studies, Eliquis side effects and the most common reason for discontinuation of the medication was “bleeding-related adverse reactions.”

In the ARISTOTLE study, the rate of bleeding related Eliquis side effects occurred in 1.7% of patients, and the AVERROES study included a rate of bleeding related Eliquis side effects that occurred in 1.5% of patients.