Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation. Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.Instruct patients not to consume alcohol or any product containing alcohol while taking OPANA ER because co-ingestion can result in fatal plasma oxymorphone levels.If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available ( 5.4). Prolonged use of OPANA ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.Accidental ingestion of OPANA ER, especially by children, can result in fatal overdose of oxymorphone.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.

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