- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
FDA Approves Eliquis (Apixaban) to Reduce Stroke, Blood Clots in Patients With Atrial Fibrillation
Agency cites risk of potentially fatal bleeding (Dec. 28)
The FDA has approved the anticlotting drug Eliquis (apixaban, Bristol-Myers Squibb/BMS/Pfizer), an oral tablet used to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation that is not caused by a heart-valve problem.
Atrial fibrillation — one of the most common types of abnormal heart rhythm — is an abnormal, irregular, and rapid beating of the heart in which the heart’s atria do not contract properly, allowing blood clots to form in them. These clots can break off and travel to the brain or to other parts of the body.
The safety and efficacy of Eliquis in treating patients with atrial fibrillation not caused by cardiac valve disease were studied in a clinical trial that compared Eliquis with the anticlotting drug warfarin in more than 18,000 patients. In this study, patients taking Eliquis had fewer strokes than had those treated with warfarin.
Patients with prosthetic heart valves should not take Eliquis, nor should patients with atrial fibrillation that is caused by a heart-valve problem. These patients were not studied in the pivotal clinical trial of Eliquis versus warfarin. As with other FDA-approved anticlotting drugs, bleeding — including life-threatening and fatal bleeding — is the most serious risk with Eliquis. No agent can reverse the drug's anticoagulant effect.
Source: FDA; December 28, 2012.