FDA approvals

FDA approves Eliquis to prevent stroke, blood clots in AF

The anti-clotting drug apixaban, an oral tablet used to reduce the risk for stroke and systemic embolism, recently received FDA approval for use in patients with atrial fibrillation not caused by cardiac valve disease, according to a press release. 

In clinical trials of more than 18,000 patients, researchers evaluated the safety and efficacy of apixaban (Eliquis, Bristol-Myers Squibb) compared with warfarin. Patients taking apixaban experienced fewer strokes than those who took warfarin, the press release stated.

Patients with prosthetic heart valves should not take apixaban nor should patients with AF that is caused by a heart valve problem, as these patients were not studied in the trial. As with other FDA-approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, is the most serious risk with apixaban. There is no agent that can reverse the anticoagulant effect of apixaban.

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

The anti-clotting drug apixaban, an oral tablet used to reduce the risk for stroke and systemic embolism, recently received FDA approval for use in patients with atrial fibrillation not caused by cardiac valve disease, according to a press release. 

In clinical trials of more than 18,000 patients, researchers evaluated the safety and efficacy of apixaban (Eliquis, Bristol-Myers Squibb) compared with warfarin. Patients taking apixaban experienced fewer strokes than those who took warfarin, the press release stated.

Patients with prosthetic heart valves should not take apixaban nor should patients with AF that is caused by a heart valve problem, as these patients were not studied in the trial. As with other FDA-approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, is the most serious risk with apixaban. There is no agent that can reverse the anticoagulant effect of apixaban.

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