Label Changes for:
Aggrenox (aspirin/extended release dipyridamole) 25 mg/200 mg Capsules
September 2012
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2012
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Bleeding
- AGGRENOX increases the risk of bleeding. Risk factors for bleeding include the use of other drugs that increase the risk of bleeding (e.g., anti-platelet agents, anticoagulants heparin, fibrinolytic therapy, and chronic use of NSAIDs) [see Drug Interactions (7.1)]
7 DRUG INTERACTIONS
7.1 Drug Interaction Study Information Obtained From Literature
- Co-administration with anti-coagulants, anti-platelets, or NSAIDS can increase risk of bleeding
