Medicine

FDA says children should not take certain medications

FDA says children should not take certain medications”

Now, the US' FDA is restricting the use of codeine and tramadol medicines in children due to risks including slowed or hard breathing and death, "which appear to be a greater risk in children younger than 12 years".

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.

Nursing mothers who are taking codeine or tramadol can pass unsafe levels of opioids to their babies through breast milk.

A 2012 review of pediatric deaths linked to codeine use resulted in an FDA boxed warning restricting its use in children younger than 18 years to treat pain after surgery to remove tonsils and adenoids.

The FDA will continue to monitor this safety issue and is considering an FDA Advisory Committee meeting to discuss the role of prescription opioid cough-and-cold medicines in children.

Regulators in Europe, Canada and Australia have all restricted the use of medicines containing codeine for children.

Codeine and tramadol are opioid medications used to treat pain.

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, like obstructive sleep apnea or lung disease. Tramadol is not approved for any uses in children, but it is commonly prescribed off-label to children anyway.

Read the label to make sure the medicine doesn't have codeine or tramadol. And the FDA also says such drugs can be risky to youths between 12 and 18. A similar search for tramadol identified nine cases worldwide of respiratory depression in children 18 years of age, including three deaths; respiratory depression typically occurred within the first 24 hours of drug administration.

"We understand there are limited options when it comes to treating pain and cough in children", Throckmorton said. They also can ask their doctor or pharmacist if a specific medication contains codeine or tramadol. However, please know that our decision today was made based on the latest evidence and with this goal in mind: "keeping our kids safe".

Meanwhile, the FDA advises Clinicians to refer parents to seek over-the-counter products or possibly FDA-approved prescription medicines that are not fatal to kids under 12-years old.

Unlike adults, some children don't metabolize the drug, which prompts adults to give a higher dose in order for the medication to be effective.

There are also alternative OTC and prescription medications available for cough. After several deaths were reported, the American Academy of Pediatrics warned parents against giving codeine to children a year ago.



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