FDA Joint Committee Votes Opana ER Risks Outweigh Benefits

The benefits of oxymorphone hydrochloride extended-release tablets (Opana ER, Endo Pharmaceuticals) do not outweigh its risks to public health, according to a joint FDA advisory committee.

Members of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee held a two-day meeting and voted 18-8—with one abstention—that the drug’s risk–benefit ratio has changed for the worst. Most of the panelists agreed that