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.
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Public Citizen Strikes Out In Call For Opioid Approval Moratorium After Recent Win
Petition was consumer advocacy group's first request for halt to approval of an entire drug class; Public Citizen has gotten full and partial approval of other recent petitions.
FDA Forced To Update Approved Products List In Do-Not-Compound Review
ANDAs mistakenly still are cataloged as approved even though they have been withdrawn from marketing.
Public Citizen’s Health Group Changes Leadership, But Wolfe Remains On Prowl
Wolfe steps down to become senior advisor but remains a vocal critic of the pharmaceutical industry and FDA, as his appearance at the Avandia advisory committee meeting demonstrated.