The FDA on Thursday said it will require a safety label change for cough and cold treatments containing codeine or hydrocodone to indicate these medications are no longer safe for use in children.
The organization announced that it will require safety labeling changes on medications containing certain drugs because they could pose serious risks for children under the age of 18. Labeling for the medications also is being updated with additional safety information for adult use - including an expanded Boxed Warning, the FDA's most prominent warning? notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or hard breathing that can result from exposure to codeine or hydrocodone.
According to the FDA, labeling for adult-only use of prescription opioid cough and cold medicines that contain codeine or hydrocodone will also now include updated safety information.
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After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. FDA is also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.
Codeine and hydrocodone are available in combination with other medicines, such as antihistamines and decongestants, in prescription medicines to treat coughs and symptoms associated with allergies or the common cold. 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.
So what's the advice for parents who may be using these medicines for their child already? These include over-the-counter (OTC) products such as dextromethorphan, as well as prescription benzonatate products. 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.
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The FDA will remind parents that most coughs and colds don't need any treatment at all.
These requirements made on Thursday pertain to medicines containing codeine or hydrocodone in children younger than 18-years-old.
It's always important to read medicine labeling, too - even if it's not obtained by prescription. Past year the restrictions were expanded to include safety labels that carried the contraindication warning, the FDA's most severe warning, to say that it should not be used for patients under the age of 12.
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