The blood thinner Eliquis (apixaban) has a new black box warning that prematurely discontinuing therapy for reasons other than pathological bleeding or completion of a course of therapy increases the risk of blood clots. If therapy is prematurely discontinued, it is advised that patients be given another anticoagulant to prevent this risk.
Eliquis is used to reduce the risk of strokes or blood clots in patients with a common heart rhythm abnormality known as atrial fibrillation, not caused by a heart valve problem. It is also approved to prevent and treat blood clots in the veins of the legs, known as deep vein thrombosis, or lungs, called pulmonary embolism. It is also used to prevent blood clots from forming in the legs and lungs of people who have just had hip or knee replacement surgery.
The new boxed warning is the second for Eliquis. The drug’s label also includes a warning for spinal/epidural hematoma in patients treated with Eliquis who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis.
Eliquis already carries a warning that use of the medication may cause bleeding which can be serious and even life threatening. Both bleeding risks and blood clot risks are common among all blood thinners including warfarin and Pradaxa.
Boxed warnings, also called black box warnings, are the most serious type of warning the Food and Drug Administration (FDA) requires and signifies that medical studies indicate that the drug carries a significant risk of serious or evening life threatening side effects or adverse events.