FDA Changes Safety Label for Pediatric Prescription Opioid Medication

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FDA Changes Safety Label for Pediatric Prescription Opioid Medication

According to a statement from the agency, the safety labeling changes are meant to limit the use of these medications in children younger than 18 years old, as these products could be associated with risks.

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.

Thursday's action expands a previous warning, issued by the agency last April, against the use of prescription medications containing codeine and tramadol for children younger than 12.

The US Food and Drug Administration (FDA) on Thursday announced safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone as the risks of these medicines outweigh their benefits in children younger than 18.

The label change also proceeds a pediatric restriction set past year that required a contraindication to prescription codeine product labels.

The FDA said it conducted extensive reviews of available data and sought expert advice on opioid use in the treatment of childhood pain and cough. We know that any exposure to opioid drugs can lead to future addiction.

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 F-D-A says it is revising warnings on such products, and will label them for use *only* in adults over age 18. Experts noted that most pediatric cough symptoms that are caused by a cold or upper respiratory do not typically require treatment with these products.

Common adverse effects of opioid therapies include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache, according to the FDA.

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