FDA further restricts pain medication use in kids

Posted April 22, 2017

The FDA also added a new "Black Box" warning label against using codeine or tramadol medicines in children aged 12-18 years old who are obese, have obstructive sleep apnea, or serious lung diseases. "They can cause a lot of harm when they're not", said the FDA's Dr. There are serious risks associated with the drugs, including slowed or hard breathing and death, which appear to be a greater risk in children younger than aged 12 years.

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A contraindication to the codeine and tramadol labels alerting users that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 year sold. In that warning, the agency noted that some people are what's known as ultra-rapid metabolizers of tramadol and codeine. 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.

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Finally, the FDA said that these drugs should not be used in children 12 to 18 who are obese, suffer from obstructive sleep apnea or have a weakened respiratory system, as they can increase the chances of risky breathing problems. This new action further limits the use of these medications beyond the 2013 restriction of codeine use in children 18 years to treat pain after surgery to remove the tonsils and/or adenoids. Tramadol is a prescription drug approved only for use in adults to treat moderate to moderately severe pain. The problem is that nursing mothers who use codeine or tramadol can pass risky levels of opioids to their infants through breastmilk. Since some medicine contains narcotics like codeine and tramadol that are proven to be fatal to kids.

FDA statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs, Center for Drug Evaluation and Research, on new warnings about the use of codeine and tramadol in children & nursing mothers. According to the FDA's public label database, more than 100 medications containing codeine are approved for sale without a prescription in the U.S.

"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". In addition, the Agency is considering more regulation surrounding OTC codeine products that are available in some states.

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

The FDA officials also urged parents to check the ingredients of over-the-counter medications and to be extremely careful of giving children any that contain codeine.

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