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FDA Warns About Pain Pill in Kids

The Food and Drug Administration says it’s investigating the use of a pain pill called tramadol in children and teens under the age of 17 because some of them can develop dangerously slow breathing.

The drug’s not approved for use in children but the FDA says doctors often prescribe it to them anyway. Such “off-label” use is legal but not recommended when it comes to kids.

“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 in a statement.

“This risk may be increased in children treated with tramadol for pain after surgery to remove their tonsils and/or adenoids.”

Tramadol is an opioid, and the body converts it to a morphine-like drug when it’s taken. All drugs in this class can slow breathing, often to a deadly degree.

The problem is that some people are “ultra-metabolizers” of the drug, FDA said. That means their livers convert it into the active form more quickly and efficiently than most people, resulting in a type of overdose.

“Recently, a 5-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 FDA said.

“The child was later found to be an ultra-rapid metabolizer.”

The FDA recently approved a different pain drug, oxycontin, for use in children. FDA approval means there are guidelines for how to prescribe the drug in teens and young children.

“Treating pain in children is important because it can lead to faster recoveries and fewer complications,” the FDA said.

“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.”

Tramadol’s sold under the brand names Ultram, Ultram ER, Conzip, Ultracet and also as a generic.