Label Changes for:
Darvon (propoxyphene hydrochloride) capsules, Darvon-N (propoxyphene napsylate) tablets, and Darvocet-N (propoxyphene napsylate and acetaminophen) tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009
Revised REMS approved and includes:
- The new safety information pertains to the risk of overdose and the potential to affect cardiovascular events,
including life-threatening arrhythmias, associated with the use of propoxyphene products.