FDA further restricts pain medication use in kids

by Noah Mcgee April 22, 2017, 1:47
FDA further restricts pain medication use in kids

Since it's almost impossible to identify the "ultrarapid metabolizers" or who may be especially sensitive or at higher risk of adverse events from the said opioid medications, the FDA now calls for stringent labeling requirements for manufacturers of codeine- or tramadol-containing drugs.

Furthermore, the FDA also added that children ages 12 to 18 should also be warned against the use of medicine codeine or tramadol.

The agency in 2013 had warned against use of codeine and tramadol in children and adolescents to treat pain after surgery to remove tonsils.

FDA announced Thursday that it is restricting the use of codeine and tramadol medicines in children.

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"It's very hard to determine which child or mother has this risk, so that's why we've taken this action today", Dr. Douglas Throckmorton, deputy center director for regulatory programs at the FDA's Center for Drug Evaluation and Research, said in a media briefing Thursday. Some children and adults break down codeine and tramadol into their active forms faster than other people. For children 12 years of age and in adolescents 18 years old (especially those with certain genetic factors, obesity, or obstructive sleep apnea and other breathing problems), clinicians should recommend over-the-counter (OTC) or other FDA-approved medications for cough and pain management. Tramadol is not approved for any uses in children, but it is commonly prescribed off-label to children anyway. A search of the FDA Adverse Event Reporting System (FAERS) database from January 1969 to May 2015 identified 64 worldwide cases of respiratory depression, including 24 deaths, with codeine-containing medications in children 18 years old.

Read the label to make sure the medicine doesn't have codeine or tramadol. In all cases, if the medicine contains codeine or tramadol, parents should consult a health care provider before giving their children the medicines or taking them when nursing. As a result, the American Academy of Pediatrics issued a policy statement warning against the use of such medicine on kids in 2016, claiming that using such medicine can result in serious breathing problems. However, with the limited options available when it comes to treating pain and cough in children, it may be harder to find the appropriate medical approach. Since some medicine contains narcotics like codeine and tramadol that are proven to be fatal to kids.

Conclusively, parents should actively check for any warning labels on medication that they plan to give to their children. We also encourage parents to review the ingredients of pain medicines to see whether they include codeine or tramadol, and cough medicines to see if they contain codeine.


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