FDA approves first generics of Eliquis (apixaban) – Drug Information Update | FDA

FDA approves first generics of Eliquis | FDA

The U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. 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. Apixaban will be dispensed with a Medication Guide for patients that provides 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 (bleeding outside of blood vessels) 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 anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, is the most serious risk with apixaban.

Read More