FDA Toughens Warning on Opioid Cough and Cold Medicines

Citing safety concerns about opioid exposure in children, the U.S. Food and Drug Administration (FDA) has mandated new labeling requirements for prescription cough and cold medicines that contain codeine or hydrocodone, limiting their indicated use to adults 18 years and older.

The FDA is requiring the relabeling after conducting an internal review and convening a panel of external experts. Both reviews determined the risks of the opioid medications (such as slowed or difficult breathing, misuse, abuse, addiction, overdose, and death) exceeded the benefits in patients younger than 18. For those children in whom cough treatment is necessary, the FDA recommends alternative medicines, such as over-the-counter (OTC) products such as dextromethorphan, as well as prescription benzonatate products.

The relabeling requirement affects both the Boxed Warning, considered the FDA’s strictest warning, as well as the Warnings and Precautions information for these medicines: both will now state that such medicines are not indicated for pediatric use. However, the new warnings only apply to opioid-containing cough and cold medicines that require a prescription. Some states allow codeine-containing cough medicines to be sold over the counter, and the FDA is still considering whether to take regulatory action for these products as well.

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