FDA further restricts pain medication use in kids

FDA Updates Restrictions of Codeine and Tramadol Use in Children, Nursing Mothers
FDA: No Codeine or Tramadol for Children Under 12 -- Period
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22 April, 2017

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 unsafe breathing problems. Additionally, the FDA recommends breastfeeding mothers not take these medications due to the risk of serious adverse reactions in breastfed infants.

In addition to these labeling changes, the FDA has added post-operative pain management for children up to age 18 years of age who have undergone tonsillectomy and adenoidectomy.

In the body, opioid painkillers and cough medicines are broken down into morphine.

In 2015, the FDA acknowledged that although tramadol is not approved for use in children, it is used off-label to treat pain in kids.

These medicines can cause life-threatening breathing problems in children.

In its statement, the FDA has rounded up a list of codeine-containing drugs to watch out for - such as codeine sulfate, codeine phosphate, Butalbital, Acetaminopen, Tylenol, Promethazine, Prometh VC, Triacin-C, Tuxarin ER, and Tuzistra-XR. Apparently, narcotics such as codeine and tramadol can be fatal when used by children. They include the FDA's strongest warning, a "contraindication", specifying that tramadol should not be used in children who have had their tonsils removed.

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Narcotics such as codeine and tramadol are not only fatal to kids under 12 years of age, but also have negative effects on nursing mothers, a report by CBS News suggests.

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

"These medications carry serious risks, including slowed or hard breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children", the FDA said in a statement released on Thursday. It also identified three deaths and six other cases of serious breathing problems reported between January 1969 and March 2016 in children taking tramadol.

The new warnings did not further restrict over-the-counter medicines that contain codeine, such as popular types of cough syrup and medication marketed for cold and flu symptoms.

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". After several deaths were reported, the American Academy of Pediatrics warned parents against giving codeine to children past year.

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


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