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
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