Label Changes for:
Adenoscan (adenosine) 3 mg/mL injection
November 2009
Changes have been made to the WARNINGS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009
WARNINGS
Atrial Fibrillation
- Atrial fibrillation has been reported in patients (with and without a history of atrial fibrillation) undergoing myocardial perfusion imaging with adenosine infusion. In these cases, atrial fibrillation began 1.5 to 3 minutes after initiation of adenosine, lasted for 15 seconds to 6 hours, and spontaneously converted to normal sinus rhythm.
