FDA Warns of Risks Associated with Tramadol Use in Children

FDA Warns of Risks Associated with Tramadol Use in Children
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September 21, 2015

The U.S. Food and Drug Administration (FDA) is investigating the use of tramadol in children aged 17 and younger.

The pain medication is not currently approved by the FDA for use in children, but data indicates that it is being used "off-label" in the pediatric population. The concern comes from the rare but serious risk that tramadol use will result in slowed or difficult breathing. The hazard may be specific in children who have recently undergone surgery for the removal of tonsils and/or adenoids.

Parents who administer tramadol to their children should go to the emergency room if they notice any signs of low or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness.

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 the brand names Ultram, Ultram ER, Conzip, and also as generics. Tramadol is also available in combination with the pain reliever acetaminophen under the brand name Ultracet and as generics.

Treating pain in children is important because it can lead to faster recoveries and fewer complications. Untreated pain can potentially result in long-term physical and psychological consequences. There are other pain medicines available that do not have this side effect of slowed or difficult breathing associated with tramadol and are FDA-approved for use in children.