Label Changes for:

Darvon (propoxyphene hydrochloride) capsules, Darvon-N (propoxyphene napsylate) tablets, and Darvocet-N (propoxyphene napsylate and acetaminophen) tablets

September 2009

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009

 REMS 

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.
Hide
(web3)