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22 April 2017, 01:43 | Violet Powell
The U.S. Food and Drug Administration (FDA) Thursday advised against the use of two narcotic painkillers - codeine and tramadol - on children under 12 and nursing mothers.
The Food & Drug Administration began tracking reports of children suffering unsafe side effects from the pain meds codeine and tramadol in 1969, and now, almost 50 years later, the agency is finally taking tough action against the manufacturers of those medicines.
Additionally, the FDA recommended breastfeeding mothers not use codeine and tramadol medicines "due to possible harm to their infants".
Kids under 18 also should not be given tramadol to treat pain following surgery to remove the tonsils or adenoids, the agency said.
Products containing codeine or tramadol will now carry a "Contraindication" for children under the age of 12, which is the FDA's strongest warning.
"It's very hard to determine which child or mother has this risk, so that's why we've taken this action today", Dr. Douglas Throckmorton, deputy center director for regulatory programs at the FDA's Center for Drug Evaluation and Research, said in a media briefing Thursday.
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Children's bodies tend to process opioids more quickly than most adults, due to their smaller size. Presently, codeine is approved to treat pain and cough - including as a frequent ingredient in prescription cough syrups - and tramadol is approved 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. 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.
FILE - In this photo taken October 14, 2015, file photo, the Food & Drug Administration campus in Silver Spring, Md. The agency also found, in a review of the medical literature, a report of an infant who died after being exposed to codeine while breast-feeding. They also can ask their doctor or pharmacist if a specific medication contains codeine or tramadol.
Codeine is an opioid prescribed for pain relief but is also combined with other medications, such as 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 health care providers and parents". These can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.
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