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
consumers and healthcare professionals be aware of this new update. The FDA has provided a list of prescription cold and cough medicines that the age limit has now changed for. These products will no longer be indicated for use in children of 18 and younger, and their use in this age group is not recommended. Health care professionals should reassure parents that coughing due to a cold or upper respiratory infection is self-limited and generally does not need to be treated. For those children in whom cough treatment is necessary, alternative medicines are available. These include over-the-counter products such as dextromethorphan, as well as prescription benzonatate products.
The FDA also stressed to parents and caregivers that they should be aware of prescription opioid cough and cold medicines that include codeine or hydrocodone. These medicines should not be used in children under any circumstances. Codeine and hydrocodone are narcotic medicines called opioids and may carry serious risks when used in children. If a cough medicine is prescribed, ask your child’s health care professional or a pharmacist if it contains an opioid such as codeine or hydrocodone and always inquire about non-opioid options.
From the recent outpour of rappers coming clean and even boasting about their lean usage, the promethazine with codeine, Sprite, and Jolly Rancher candy concoction can really do some damage. It’s a narcotic stimulant that can have a fatal outcome.
Tia Muhammad, BS, is an award-winning freelance content & media creative, copywriter, blogger, digital designer, and marketing consultant. She owns the boutique content and digital media company, jackieGLDN|studio.
SOURCES:
FDA.gov, FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older, Jan. 11, 2018
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