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Some of the reported cases followed tonsillectomy and/or adenoidectomy in at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism. Life-threatening respiratory depression and death have occurred in children who received tramadol.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.

If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Prolonged use of tramadol hydrochloride tablets, during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life threatening if not recognized and treated.

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.

Accidental ingestion of tramadol hydrochloride tablets, especially by children, can result in a fatal overdose of tramadol.

Monitor closely, especially during initiation or following a dose increase.

Serious, life-threatening, or fatal respiratory depression may occur.

Assess each patient’s risk prior to prescribing tramadol hydrochloride tablets, and monitor regularly for these behaviors or conditions.

Tramadol hydrochloride tablets exposes users to the risks of addiction, abuse and misuse, which can lead to overdose and death.

See full prescribing information for complete boxed warning. WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TRAMADOL HYDROCHLORIDE

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