FDA further restricts pain medication use in kids

Judith QuinnApr 22, 2017

USA regulators are strengthening warnings about the dangers of two types of powerful opioid painkillers, codeine and tramadol, due to risks of slowed breathing and death.

Children metabolize these medications much faster than adults, which can cause the active ingredients to rise in their bloodstreams to dangerously high levels, the agency said.

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.

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Tramadol, another opioid painkiller, was also mentioned in the most recent FDA warning. 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.

Codeine and tramadol medicines will now carry a "Contraindication" in children under 12 years old, which is the strongest drug warning label the FDA can add.

A new contraindication to the tramadol label warning against its use in children younger than 18 years old to treat pain after surgery to remove the tonsils and/or adenoids.

Almost 1.9 million kids aged 18 or younger received a prescription for a codeine-containing medication in 2014, and almost 167,000 were prescribed a medication containing tramadol, the FDA said. There is also a strengthened "Warning" advising against the use of these products among breastfeeding mothers, as it may cause serious harm to their infants.

"Today's actions build on a better understanding of this very serious safety issue, based on the latest evidence", Throckmorton said.

In light of these narcotics that are fatal to kids, the FDA has been evaluating the use of codeine and tramadol in children ages 17 and below since 2015.

"We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents". Those infants can become too sleepy, have difficulty breastfeeding, or have serious breathing problems.

Numerous products containing these drugs are only available by prescription, but several over-the-counter cough medicines contain codeine. Codeine products are available by prescription and, in some states, over-the-counter (OTC).

Moreover, in order to counter pain and coughing, parents are advised to discuss alternative pain medications for their children with their doctors.

Conclusively, parents should actively check for any warning labels on medication that they plan to give to their children. They also can ask their doctor or pharmacist if a specific medication contains codeine or tramadol.

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