Cold/Flu Safety: Opioid Cough & Cold Medicines 18 & Older Only

Although we may let our kids sing along to the latest in ‘lean’ infused music, that doesn’t mean the FDA is here for it. Whether your child knows what ‘purp’, ‘sizzurp’, promethazine, and codeine really is or not, the U.S. Food and Drug Administration knows exactly what it is and what people are doing with it. And they’re labeling it loud and clear.

According to a recent FDA Drug Safety communication, the FDA is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18.

The FDA is also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing be added to the boxed warning label. A more prominent warning label will now be attached to drug labels for prescription cough and cold medicines containing codeine or hydrocodone.

Although some codeine cough medicines are available over-the-counter in a few states, the FDA is still considering regulatory action for these products as well.

The FDA recently took action on the labeling after conducting an extensive review and assembling a panel of outside experts on the issue. The outcome brought to light the undeniable side effects of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines in patients younger than 18. Significantly outweighing their benefits to colds and the flu.

It is recommended by the FDA that