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

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

Codeine, an opioid pain medication, is often used to treat mild to moderately severe pain, and doctors say it can cause some serious problems for children in particular. In some cases, codeine breaks down rapidly in the liver and that results in higher than normal levels showing up in the body. And the FDA is leaving no room for doubt in a recent finding when it comes to using the drug on children younger than 12.

The recent notification from the FDA says those under 12 should not take codeine at all, and as the drug is found in some cough and pain medicines, the Food and Drug Administration (FDA) edict now aims to restrict the use of the drug for kids.

This FDA release calls on parents to closely read ingredient labels on pain – and cough medicines in particular – to make certain the medications they give their kids don’t contain codeine or a variant known as tramadol.

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The FDA announcement also makes changes to requirements for the labels of drug treatments which contain codeine. The agency says the move was driven by the fact that some reports have found that children can experience life-threatening breathing problems – and perhaps die – after taking medicines which contain codeine. According to the findings, during the period from 1969 to 2015 the FDA received more than 60 reports of serious breathing problems which were directly tied to the use of medicines which contained codeine in children. Of those cases, 24 of them resulted in death. In particular, the data showed the most serious side effects resulting from the use of the drug happened in in children under 12 years old.

The new warnings also include recommendations against the use of tramadol in children under 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 found in certain over-the-counter cough medicines and prescription pain and cough medicines. The FDA says tramadol is found in some prescription pain medicines, though it is only approved for adult use. In addition, the FDA said codeine should not be used for teens ages 12 to 18 if those patients are obese, have conditions such as obstructive sleep apnea or suffer from severe lung disease.

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