22 April, 2017
The FDA said Warning labels on medications with codeine or tramadol will be strengthened to reflect these dangers. the agency said Nursing mothers should also avoid using these drugs.
The majority of serious side effects occurred in children younger than 12, sometimes after a single dose, the FDA said.
The agency said that a safety review of adverse events reports submitted to the FDA from January 1969 to May 2015 identified 64 cases of serious breathing problems, including 24 deaths, involving codeine-containing medicines in children younger than 18.
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These medicines should not be used in these children, the FDA says, and should also be limited in some older children. That can cause the level of narcotics in the bloodstream to rise too high and too quickly, risking overdose in children, due to their smaller size.
Douglas Throckmorton, a top official at the FDA's Center for Drug Evaluation and Research, said in telephone briefing for reporters that the safety hazards are the result of the "unique way" these medications are broken down in the bodies of some children and adults.
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The agency said it would require manufacturers to make label changes to warn that the drugs shouldn't be used for anyone under 12 and should be restricted in older children. It is frequently combined with other drugs in prescription and over-the-counter (OTC) cough and cold medicines.
The agency noted that since 2013, prescription products containing codeine have contained a boxed warning and contraindication for children and teens up to age 18 for pain management after removal of tonsils and adenoids.
The FDA labeled the drugs with their strongest warning, called the "contraindication", to alert consumers to always read the label on prescription bottles to find out if a medicine contains codeine or tramadol. However, please know that our decision today was made based on the latest evidence and with this goal in mind: "keeping our kids safe". If a codeine-or tramadol-containing product is determined to be appropriate for an adolescent patient, clinicians should provide counseling on how to recognize the signs of opioid toxicity. These signs include slow or shallow breathing, difficulty or noisy breathing, confusion, more than usual sleepiness, trouble breastfeeding, or limpness.
Aside from breathing issues, codeine also causes nausea, vomiting, abdominal pain, constipation, and skin allergies. After several deaths were reported, the American Academy of Pediatrics warned parents against giving codeine to children previous year.
Conclusively, parents should actively check for any warning labels on medication that they plan to give to their children.