FDA further restricts pain medication use in kids

A strengthened warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants, which can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.

On Thursday, the U.S. Food and Drug Administration warned that Parents shouldn't give their children medications containing the narcotics codeine or tramadol.

Among the updates are contraindications for use of codeine or tramadol in all children younger than 12 years, warnings about their use in children 12-18 years of age with certain medical conditions, and a stronger warning recommending against their use in nursing mothers.

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

The warnings will only apply to prescription drugs; some products with codeine are available over the counter.

The agency on Thursday ordered several alternations in labels to underscore the risks of the drugs to children. These people have a genetic feature that prompts the liver to convert codeine into life-threatening or fatal amounts of morphine in the body.

Codeine and tramadol are opioid medications used to treat pain.

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Unlike codeine, tramadol wasn't FDA-approved for pediatric patients; however, in September 2015, the agency noted it was likely being used off-label in children.

Youths ages 12 through 18 who are obese or have obstructive sleep apnea (blocked airflow during sleep) or a weakened respiratory system shouldn't take codeine or tramadol. Tramadol will now also carry a similar warning label. It is frequently combined with other drugs in prescription and over-the-counter (OTC) cough and cold medicines.

"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 healthcare providers and parents", said Throckmorton.

"Today's actions build on a better understanding of this very serious safety issue, based on the latest evidence", Throckmorton said. Since some medicine contains narcotics like codeine and tramadol that are proven to be fatal to kids.

At the time, pharmacist Maria Pruchnicki, an associate professor at the Ohio State University College of Pharmacy, told NPR's Rob Stein, "My concern, were I to be prescribing codeine in children, would be that I would, frankly, kill them". 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.

For more on opioid medications in children, visit the Boston Children's Hospital.

  • Marjorie Miles