The Medical Letter on Drugs and Therapeutics
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1521
FDA Warns Against Use of Codeine and Tramadol in Children and Breastfeeding Women
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The FDA has issued new warnings about the use of the opioid analgesics codeine and tramadol in children, particularly those <12 years old, and in breastfeeding women due to concerns about the risk of respiratory depression and death.1 The FDA previously issued warnings about these drugs in 2013 and 2015.2-4

NEW FDA RECOMMENDATIONS — Use of codeine or tramadol in children <12 years old is contraindicated. Tramadol is also contraindicated for treatment of pain after tonsillectomy or adenoidectomy in patients <18 years old; codeine was already contraindicated for use in such patients. Codeine and tramadol are not recommended for any indication in children 12-18 years old who are obese or have an increased risk of serious breathing problems, such those with obstructive sleep apnea or severe lung disease. Breastfeeding women ... more       Show References Hide References

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Title: FDA Warns Against Use of Codeine and Tramadol in Children and Breastfeeding Women
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