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  • Safety Labeling Changes for Pediatric Opioid Cough and Cold Preparations

    Reducing the opioid epidemic is a critical healthcare focus, including avoidance of unnecessary exposure to opioids in young children. After extensive data review, the FDA concluded that the risks connected with opioid use in children younger than 18 outweigh any potential benefits. Labeling for prescription opioid cough and cold medicines containing codeine or hydrocodone is now limited for use only in adults who are 18 years or older. In addition, the FDA now requires an expanded Boxed Warning for these medications that highlights their risks for misuse, abuse, addiction, overdose, death, and slowed or difficult breathing.

    These new requirements build on previous restrictions enacted in 2017, when the FDA called for the addition of a contraindication warning to labeling to advise against use of tramadol-containing medications in children younger than 12 years old, and also against the use of codeine-containing medications in this population due to the risk of ultra-rapid metabolism in certain patients. These products were also contraindicated in postoperative management of children younger than 18 years of age post-tonsillectomy and/or adenoidectomy.

    The FDA’s most recent changes were based on review of adverse events reports submitted during 1969 through 2015; there were 64 cases of serious breathing problems, including 24 deaths, associated with children younger than 18 years old who took medicines containing codeine. Both codeine and hydrocodone are associated with respiratory depression and death, particularly in pediatric patients. Metabolism for hydrocodone has not been identified as a risk factor the way codeine has.

    Most pediatric cough symptoms caused by a cold or upper respiratory tract infection do not typically require treatment with opioids, and the FDA advises healthcare professionals to educate caregivers that a cough in children due to these conditions is self-limited and generally does not need to be treated. For children in whom cough treatment is necessary, alternative medicines are available. These include over-the-counter products, such as dextromethorphan, as well as prescription benzonatate products.

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    Benefit/Risk Assessment of Prescription Opioid Antitussive Products for Treatment of Cough in Pediatric Patients. Background Document Pediatric Advisory Committee Meeting September 11, 2017. FDA website. https://www.fda.gov/downloads/.../PediatricAdvisoryCommittee/UCM573222.pdf. Accessed April 6, 2018.

    FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric use. FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592109.htm. Accessed April 6, 2018.

    FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older. FDA website. https://www.fda.gov/Drugs/DrugSafety/ucm590435.htm. Accessed April 6, 2018.

    FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. FDA website. https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm. Accessed April 6, 2018.