The United States Food and Drug Administration (FDA) has reported investigation on the Health Risk of using Tramadol in Pain Relive in children aged 17 years and younger, because of the rare but serious risk of slowed or difficult breathing. This risk may be increased in children treated with tramadol for pain after surgery to remove their tonsil and /or adenoids.
Tramadol is a specific type of narcotic medicine called an opioid that is approved to treat moderate to moderately severe pain in adults. It is available under various brand names in combination with the pain reliever acetaminophen and as generics.
According to FDA Tramadol is not approved for use in children; however, data show it is being used “off-label” in the pediatric population.
Health Effects of Tramadol
Action required from Prescriber/Patients
- Health care professionals should be aware of this and consider prescribing alternative approved pain medicines 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.
- Report adverse events or side effects related to the use of Tramadol in children to NAFDAC PRASCOR system.
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