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FDA further restricts pain medication use in kids

FDA further restricts pain medication use in kids

The U.S. Food and Drug Administration has released an official safety announcement on Thursday, April 20, warning against the use of codeine in children younger than 12 years of age.

The FDA also warns against using the drugs in those between 12 and 18 who are obese or have breathing problems such as sleep apnea or lung disease.

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The agency listed 15 medicines affected by the action, plus all of their generics, which included J&J's Tylenol with codeine and Vertical's tramadol med ConZip. Those people have a variant of a liver enzyme that breaks down the drugs more quickly, leading to a rapid and potentially unsafe spike in the level of active opioids in the bloodstream.

There are some people who are "ultrarapid metabolizers" or whose livers process the drugs way too quickly, which is not good because it can lead to dangerously high levels of opioids to build up in the body, Dr. Douglas Throckmorton, the deputy center director for regulatory programs at the FDA's Center for Drug Evaluation and Research, explained. The agency cited concerns about slowed or hard breathing or death, especially among younger children and infants in its decision to restrict the use of products containing these two drugs.

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Since 2013, FDA notes, prescription codeine labels have contained a boxed warning and contraindication for children up to age 18 years of age regarding the risk of life-threatening respiratory depression following the use of codeine for pain management after the removal of the tonsils and/or adenoids. If a codeine-or tramadol-containing product is determined to be appropriate for an adolescent patient, clinicians should provide counseling on how to recognize the signs of opioid toxicity.

The FDA is reminding healthcare professionals that tramadol and single-ingredient codeine medications are only FDA-approved for adult use.

Some of the products containing these drugs are only available by prescription, but some over-the-counter cough medicines contain codeine. Respiratory depression can also occur in nursing babies when mothers who take codeine and tramadol and pass it along to their children through their breast milk. However, please know that our decision today was made based on the latest evidence and with this goal in mind: "keeping our kids safe". It also identified three deaths and six other cases of serious breathing problems reported between January 1969 and March 2016 in children taking tramadol.

The FDA recommends that parents talk to a doctor before giving their children such drugs.

Conclusively, parents should actively check for any warning labels on medication that they plan to give to their children.

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