Instruct patients to swallow OPANA ER tablets whole to avoid exposure to a potentially fatal dose of oxymorphone. Monitor closely, especially upon initiation or following a dose increase. Serious, life-threatening, or fatal respiratory depression may occur.To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions. OPANA ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death.
WARNING: ADDICTION, ABUSE, AND MISUSE RISK EVALUATION AND MITIGATION STRATEGY (REMS) LIFE-THREATENING RESPIRATORY DEPRESSION ACCIDENTAL INGESTION NEONATAL OPIOID WITHDRAWAL SYNDROME INTERACTION WITH ALCOHOL and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES AND OTHER CNS DEPRESSANTS See full prescribing information for complete boxed warning.