FDA Investigating Off-Label Pain Med Use in Pediatric Patients

FDA Investigating Off-Label Pain Med Use in Pediatric Patients
FDA Investigating Off-Label Pain Med Use in Pediatric Patients

The Food and Drug Administration (FDA) announced that it is currently investigating the use of tramadol in children aged ≤17 due to a rare but potentially serious risk of slowed or difficult breathing, particularly in children treated with this medication after surgery to remove tonsils and/or adenoids.

Although the opioid analgesic tramadol is not currently FDA-approved for use in children, data show that it is being used “off-label” in pediatric patients. Some patients may have genetic variations that cause the drug to be converted to the active form of the opioid (O-desmethyltramadol) faster and more completely than usual. These ultra-rapid metabolizer patient are more likely to have higher-than-normal amounts of the active form of the opioid in their blood after taking tramadol, which can result in breathing difficulty that may lead to death. A 5-year-old child in France recently experienced severely slowed and difficult breathing requiring emergency intervention and hospitalization after taking a single prescribed dose of tramadol oral solution for pain relief following surgery to remove his tonsils and adenoids; the child was later found to be an ultra-rapid metabolizer and had high levels of O-desmethyltramadol in his body.

RELATED: Severe Respiratory Depression in a Child Given Tramadol for Pain Relief

The FDA urges that healthcare professionals should consider prescribing alternative FDA-approved pain medicines that do not have the potential side effect of slowed or difficult breathing for children. Parents and caregivers of children taking tramadol who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness should stop tramadol and seek medical attention immediately by taking their child to the emergency room or calling 911. Parents and caregivers are also encouraged to discuss any questions or concerns regarding tramadol or other pain medications with their child's healthcare provider. The FDA is currently reviewing all available information and will communicate final conclusions and recommendations when the assessment is complete.

For more information call (888) 463-6332 or visit FDA.gov.

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