FDA Approves First 2 Apixaban Generics

Officials with the FDA have approved 2 applications for the first generics of apixaban (Eliquis, Bristol-Meyers Squibb) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The approvals were granted to applications submitted by Micro Labs Limited, and Mylan Pharmaceuticals.

Apixaban is also indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. Additionally, apixaban is indicated for the treatment of DVT and PE and for the reduction in the risk of recurrent DVT and PE following initial therapy.

For at-risk patients, such as those with, or at risk for, DVT, or nonvalvular atrial fibrillation, the risk of stroke related to blood clots forming in the body and traveling to the brain is a serious concern. Atrial fibrillation is a heart rhythm problem that can potentially cause such blood clots.

According to the FDA, citing CDC data, it is estimated that between 2.7 and 6.1 million people in the United States have atrial fibrillation. Many of these individuals use anticoagulants or anticlotting drugs to reduce that risk.

Apixaban will be dispensed with a medication guide, which provides patients with instructions on its use, and drug safety information. Health care professionals should counsel patients on signs and symptoms of possible bleeding.

There is an increased risk of thrombotic events, which occur when blood clots form inside a blood vessel, or strokes if a patient stops using apixaban too early. Additionally, epidural or spinal hematomas may occur in patients treated with apixaban who are receiving neuraxial anesthesia or undergoing spinal puncture.

These hematomas may result in long-term or permanent paralysis. Health care professionals should consider these risks when scheduling patients for spinal procedures.

Patients with prosthetic heart valves should not take apixaban nor should patients with atrial fibrillation that is caused by a heart valve problem. As with other FDA-approved anticlotting drugs, bleeding, including life-threatening and fatal bleeding, is the most serious risk with apixaban.

REFERENCE

FDA Approves First Generics Eliquis [news release]. Silver Spring, MD; December 23, 2019: FDA website. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generics-eliquis Accessed December 23, 2019.