FDA Puts the Beat-Down On Codeine Based Products For Kids Under 12

Codeine, an opioid pain medication, is commonly used to treat mild to moderately severe pain, and doctors warn that it can cause serious problems in children. In some cases, codeine degrades rapidly in the liver, resulting in higher-than-normal levels in the body. And, when it comes to using the drug on children under the age of 12, the FDA leaves no room for doubt in a recent finding.

The FDA recently stated that children under the age of 12 should not take codeine at all, and because the drug is found in some cough and pain medications, the Food and Drug Administration (FDA) edict now aims to restrict the drug’s use for children.

This FDA release urges parents to carefully read the ingredient labels on pain medications, particularly cough medicines, to ensure that the medications they give their children do not contain codeine or tramadol.

The FDA announcement also modifies labeling requirements for codeine-containing drug treatments. According to the agency, the decision was motivated by reports that children can experience life-threatening breathing problems – and possibly die – after taking codeine-containing medications. According to the findings, the FDA received more than 60 reports of serious breathing problems in children from 1969 to 2015 that were directly related to the use of codeine-containing medicines. Twenty-four of those cases resulted in death. The data revealed that the most serious side effects of the drug occurred in children under the age of 12 years.

The new warnings also advise against using tramadol in children under the age of 12.

“Our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe,” said Dr. Douglas Throckmorton, deputy center director for regulatory programs at the FDA’s Center for Drug Evaluation and Research.

Codeine is still present in some over-the-counter cough medicines as well as prescription pain and cough medications. Tramadol is found in some prescription pain medications, according to the FDA, but it is only approved for adult use. Furthermore, the FDA stated that codeine should not be used in teens aged 12 to 18 if they are obese, have conditions such as obstructive sleep apnea, or have severe lung disease.

According to the findings, the dangerous side effects occur because some patients are “ultrarapid metabolizers” of codeine or tramadol, and Throckmorton says those patients break down those two drugs much faster than other users, exposing them to “dangerously high levels of the active drug in their bodies.”

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