FDA Tramadol Safety Communication – The pain medicine tramadol is being investigated by the U.S. Food and Drug Administration (FDA) due to a “rare but serious” risk to children aged 17 years and younger of slowed or difficult breathing.
When tramadol is used for pain after tonsil and/or adenoids surgery this risk may be increased. For example, in a recent case a 5-year-old child took a single prescribed dose of tramadol oral solution for pain relief following surgery to remove his tonsils and adenoids. Soon after he suffered severe difficulty breathing, required emergency intervention and was subsequently hospitalized.
FDA is evaluating all available information and will communicate final conclusions and recommendations to the public when the review is complete.
Off-Label Tramadol Prescribed to Children
While treating children’s pain is crucial to avoid long-term physical and psychological consequences, tramadol is not FDA-approved for children at this time. Tramadol is often prescribed “off-label”, meaning the medication is being prescribed for an indication unapproved by the FDA. Parents and medical professionals should consider use of one of the many other, approved, options for children’s pain relief.
Information on Tramadol Safety
Tramadol is available under many brand names, such as Ultram, Ultram ER, Conzip, and (combined with acetometaphin) as Ultracet, as well as generics.
The FDA urges parents to discontinue use of tramadol and seek immediate medical attention if the child is showing any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness. Additionally, if parents and caregivers have any questions or concerns they should talk with their child’s health care professional about tramadol or other pain medicines their child is taking.
Health care professionals, parents, and caregivers are urged to report side effects involving tramadol to the FDA MedWatch program.
For more information on the FDA tramadol safety communication and tramadol risks see tramadol drug safety/FDA.
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