"June 22, 2012 -- The FDA has decided -- for now -- against allowing the new blood thinner Xarelto to be used to treat patients with blocked coronary arteries.
Federal officials issued a complete response letter late Thursday, which me"...
- Patient Information:
Details with Side Effects
Overdose of XARELTO may lead to hemorrhage. Discontinue XARELTO and initiate appropriate therapy if bleeding complications associated with overdosage occur. A specific antidote for rivaroxaban is not available. Rivaroxaban systemic exposure is not further increased at single doses > 50 mg due to limited absorption. The use of activated charcoal to reduce absorption in case of XARELTO overdose may be considered. Due to the high plasma protein binding, rivaroxaban is not expected to be dialyzable [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]. Partial reversal of laboratory anticoagulation parameters may be achieved with use of plasma products.
XARELTO is contraindicated in patients with:
- active pathological bleeding [see WARNINGS AND PRECAUTIONS]
- severe hypersensitivity reaction to XARELTO (e.g., anaphylactic reactions) [see ADVERSE REACTIONS]
Last reviewed on RxList: 3/19/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Xarelto Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.