A Lack Of Data Keeps Propoxyphene On The Market ... For Now At Least
Executive Summary
The lack of clear data substantiating the risk of fatal overdose with propoxyphene-containing drug products seems to have led FDA to its decision to keep the products on the market - and thus deny Public Citizen's petition for their withdrawal
You may also be interested in...
Cardiac Risks Of Propoxyphene Raced Out Of Control As FDA Moved For Immediate Withdrawal
In deciding that the pain drug propoxyphene should come off the market, Center for Drug Evaluation and Research officials went from believing there was insufficient evidence of cardiac harm at therapeutic doses to concluding there was no way the risks of heart arrhythmia could be managed and mitigated.
Cardiac Risks Of Propoxyphene Raced Out Of Control As FDA Moved For Immediate Withdrawal
In deciding that the pain drug propoxyphene should come off the market, Center for Drug Evaluation and Research officials went from believing there was insufficient evidence of cardiac harm at therapeutic doses to concluding there was no way the risks of heart arrhythmia could be managed and mitigated.
FDA Takes Action Against Propoxyphene But Keeps It On The Market
FDA denies Public Citizen's request for withdrawal, instead mandating new studies to assess propoxyphene's link to overdoses and requiring a boxed warning and MedGuide.