FDA Updates Labeling for Opioid-Containing Medications to Limit Use in Children


Prescription opioid cough and cold medicines that contain codeine or hydrocodone are being stripped of their indications to treat cough in kids, FDA announced Thursday (Jan. 11).

Furthermore, labeling for these products will now include an expanded Boxed Warning, explaining "the risks of misuse, abuse, addiction, overdose and death, and slowed or hard breathing" that can result - even in adults.

FDA Commissioner Scott Gottlieb, MD, expressed concern for young children's unnecessary exposure to opioids in a statement.

The FDA recommends OTC products, such as dextromethorphan, as well as prescription benzonatate products when cough treatment is necessary.

The new warnings are consistent with the labels on other drug products with opioids, including painkillers.

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These prescription medicines involve any that include codeine or oxycodone, the FDA said.

The label changes, which will pertain to medicines containing codeine or hydrocodone, will also include safety information for adult use.

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

The FDA will also carry bigger warning about their dangers to adults, NBC News reported. Experts noted that most pediatric cough symptoms that are caused by a cold or upper respiratory do not typically require treatment with these products. The panel declared that the risks of using certain opioids in children's cough medications outweigh the benefits. Experts say parents should always read labels before giving their children any medicine, even if it's purchased over the counter.