New FDA Warning: Use of Codeine and Tramadol In Certain Youths, Children Under Age 12 “Carry Serious Risks”

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New FDA Warning: Use of Codeine and Tramadol In Certain Youths, Children Under Age 12 “Carry Serious Risks”

According to the U.S. Food and Drug Administration, opioid medications codeine and tramadol carry serious risks for children under age 12, such as life-threatening central nervous system depression. Therefore, they are tightening restrictions on the use of these drugs in young children.

Also, the FDA is recommending that breastfeeding mothers do not use these drugs due to the risk of possible harm to nursing babies.

Codeine is approved by the FDA to treat pain and coughing, and Tramadol is approved to treat moderate pain. Codeine is often combined with other medications such as acetaminophen and other over-the-counter cough and cold treatments.

Doug Throckmorton, MD, deputy director for regulatory programs, FDA Center for Drug Evaluation and Research stated that some children who have received these drugs have suffered from life-threatening respiratory depression and death.

He said this occurs “because they metabolize these medicines much faster than usual” and therefore result in “dangerously high levels of active drug in their bodies.”

“This is especially concerning in children under 12 years of age and adolescents who are obese or have conditions that may increase the risk of breathing problems…Respiratory depression can also occur in nursing babies…”

The FDA reviewed adverse event report from 1969-2015 and found 64 incidents of severe breathing issues in children under 18 who received codeine, resulting in 24 deaths. There were also nine incidents of severe breathing problems in children who were given tramadol, resulting in three deaths.

Most of the serious side effects resulting from the use of either drug, however, occurred in children under age 18.

The FDA now requires drug makers to add a warning label alerting providers and parents that codeine and tramadol should not be used to treat children younger than 12. Also, the label cautions aginst using these drug on adolescents younger than 18 who are obese or have sleep apnea or lung disease.

Mothers who are breastfeeding infants will also be discouraged from using codeine and tramadol

The FDA did not, however, suggest any alternatives to the opioid medications to treat a cough or pain in children.

~ G. Nathalee Serrels, M.A., Psychology

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