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FDA: Prescription Opioid Cough/Cold Meds No Longer Indicated for Children

13 January 2018

The agency said it is requiring manufacturers to change the wording on their labels to make clear that such products should not be used for anyone younger than 18.

The FDA pointed to known side effects of opioid medications, including "drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache". Greater dangers include breathing difficulties and even death.

Products covered by Thursday's announcement included four with codeine, in combination with other agents such as chorpheniramine and promethazine, and five with hydrocodone along with other ingredients. These changes include limiting the use of these agents to adults ≥18 years old, as well as the addition of new safety information regarding the risks of slowed or hard breathing, misuse, abuse, addiction, overdose, and death to the Boxed Warning. At the time, officials expressed concerns that some children are "ultrarapid metabolizers" who process such drugs very quickly, resulting in dangerously high levels that can depress breathing and lead to death. The expert panel found that the risks of slowed or hard breathing, misuse, abuse, addiction, overdose, and death with these medications outweighed their benefits in patients 18 years of age.

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The FDA took more steps Thursday to keep opioids out of children's medications, announcing changes to labels for nine types of prescription cough and cold medications containing codeine or hydrocodone, indicating that they should not be given to patients younger than 18.

"Health care professionals should reassure parents that cough due to a cold or upper respiratory infection is self-limited and generally does not need to be treated".

The move comes after a 2017 decision by the FDA to add its strongest warning - a "contraindication" - to labeling for prescription products containing codeine.

FDA: Prescription Opioid Cough/Cold Meds No Longer Indicated for Children