FDA Changes Safety Label for Pediatric Prescription Opioid Medication

The Food and Drug Administration says kids and teens should never take prescription cough and cold medicines that contain opioids.

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.

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 makers of these medicines also will need to update their labeling to provide safety warnings consistent with the labeling of other opioid-containing drugs, and will feature an expanded Boxed Warning for adult use.

The FDA made the announcement Thursday, saying, "Given the epidemic of opioid addiction, we're concerned about unnecessary exposure to opioids, especially in young children". The panel declared that the risks of using certain opioids in children's cough medications outweigh the benefits. 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 decision to limit the prescription opioid cough and cold medicine availability for pediatric patients was based on extensive data review and advisory committee input.

These prescription medicines involve any that include codeine or oxycodone, the FDA said. We know that any exposure to opioid drugs can lead to future addiction.

The FDA pointed to known side effects of opioid medications, including "drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache".

It's always important to read medicine labeling, too - even if it's not obtained by prescription.