FDA Reviewing Safety of Tramadol Use for Children

Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....

Sept. 21 — The Food and Drug Administration said Sept. 21 it's investigating the use of the pain medicine tramadol in children aged 17 years and younger because of the rare but serious risk of slowed or difficult breathing.

The agency said in an online posting that the risk may be increased in children treated with tramadol for pain after surgery to remove their tonsils and/or adenoids. “We are evaluating all available information and will communicate our final conclusions and recommendations to the public when our review is complete.”

The FDA explained that tramadol is a specific type of narcotic medicine called an opioid that is approved to treat moderate to moderately severe pain in adults. The drug is available under the brand names Ultram, Ultram ER and Conzip, and also as a generic. Tramadol is also available in combination with the pain reliever acetaminophen under the brand name Ultracet and in generic form, the FDA said.

The agency added that tramadol is not FDA-approved for use in children. However, the FDA said data show it's 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, the agency said. 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.

The FDA said 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.”

In the body, tramadol is converted in the liver to the active form of the opioid, called O-desmethyltramadol, the agency said. “Some people have genetic variations that cause tramadol to be converted to the active form of the opioid faster and more completely than usual,” the FDA said, adding that these people, called ultra-rapid metabolizers, “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.”

Recently, a five-year-old child in France 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 agency said. The child was later found to be an ultra-rapid metabolizer and had high levels of O-desmethyltramadol in his body.

More information is available at http://tinyurl.com/nhewvum