FDA Releases New Requirements For Prescription Opioid Cough And Cold Medicines

Kenny Tucker
January 13, 2018

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 decision to change the labeling was made in response to the fact that the "serious risks of these medicines outweigh their potential benefits in this population", said the announcement from the FDA. We know that any exposure to opioid drugs can lead to future addiction. FDA is also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or hard breathing to the Boxed Warning, the most prominent warning, of the drug labels for prescription cough and cold medicines containing codeine or hydrocodone. "For those children in whom cough treatment is necessary, alternative medicines are available", including OTC products such as dextromethorphan as well as prescription benzonatate products.

After the labeling changes, the products will be indicated to only be used for adults.

These new requirements expand pediatric restrictions put in place in 2017 when the FDA required the addition of the FDA's strongest warning, called a contraindication, to the labeling of prescription codeine.

Not only will these medications get new safety labeling about the age of users, they will also get new labels about safe use in general, said the FDA. That labeling restricted use to children aged 12 and over "due to a specific risk of ultra-rapid metabolism in certain patients", the FDA explained.

Gottlieb said in a statement in August that the FDA would be meeting with the Pediatric Advisory Committee to further evaluate the use of prescription opioid products containing hydrocodone or codeine to treat cough in children. Experts indicated that although some paediatric cough symptoms do require treatment, cough due to a cold or upper respiratory infection typically does not require treatment.

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Common side effects of extended opioid use include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache.

"The opioid epidemic has many origins, but can begin with exposure to [opioids] at young ages", he said.

So what's the advice for parents who may be using these medicines for their child already? Always read the labels on prescription bottles.

Parents and caregivers should be aware that prescription opioid cough and cold medicines that include codeine or hydrocodone should not be used in children.

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