The American drug regulatory agency, the US FDA has approved two applications for the first generics
) 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.
Dr Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research told Thailand Medical
News, "Today's approvals of the first generics
are an example of how the FDA's generic
drug program improves access to lower-cost, safe and high-quality medicines," "These approvals mark the first generic
approvals of a direct oral anticoagulant. Direct oral anticoagulants (blood thinners) do not require repeated blood testing."
Dealing and addressing the challenges related to developing generics and promoting more generic
competition is a key part of the FDA's Drug Competition Action Plan and the agency's efforts to help increase patient access to more affordable medicines.
For individuals classified as 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 Centers for Disease Control and Prevention, it is estimated that between 2.7 and 6.1 million people in the U.S. have atrial fibrillation. Many of these individuals use anticoagulants or anti-clotting drugs to reduce that risk.
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.
Typically, 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.
Individuals 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
The US FDA granted approval of the generic apixaban
applications to Micro Labs Limited and Mylan Pharmaceuticals Inc.