Illustration. Image: Actavis
The U.S. Food and Drug Administration (FDA) has announced that taking tramadol pain medicine for children under 17 can cause serious difficulty with breathing.
The FDA said it was investigating the use of the pain medicine tramadol in children aged 17 years and younger. The risk may be increased in children treated with tramadol for pain after surgery to remove their tonsils and/or adenoids. The FDA is evaluating all available information and said it would communicate our final conclusions and recommendations to the public when our review is complete.
Tramadol is not FDA-approved for use in children; however, data show it is being used “off-label” in the pediatric population. Health care professionals should be aware of this and consider prescribing alternative FDA-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 by taking their child to the emergency room or calling 911.
Parents and caregivers should talk with their child’s health care professional if they have any questions or concerns about tramadol or other pain medicines their child is taking.