FDA putting new limits on cold medicine for children

FDA revises labelling in prescription cough and cold products to protect children from opioids

These prescription medicines involve any that include codeine or oxycodone, the FDA said.

The organization announced that it will require safety labeling changes on medications containing certain drugs because they could pose serious risks for children under the age of 18.

Prescription opioid cough and cold medicines: Drug Safety Communication - FDA requires labeling changes.

In 2015, the FDA also announced an investigation into the possible risks of using codeine-containing medicines to treat coughs and colds in children under 18.

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. Both are opioids, meaning they're either derived from an opiate or they are synthetic, and are part of a family of narcotic drugs that are highly addictive. 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.

Though milder side effects include headaches and vomiting, opioids can cause potentially fatal breathing problems, especially in children, the FDA warns.

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. That warning was added because children are at risk for ultra-rapid metabolism, the newest announcement and expansion of labels is an expansion of that warning, said the FDA.

The new warning follows an extensive FDA review of data and a meeting of the agency's Pediatric Advisory Committee in September.

"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? "We know that some children and teens may, in fact, develop a predilection for the "high" the prescription cough syrups deliver, and subsequently attempt to deceive parents and health care providers regarding the severity of their symptoms to obtain such a prescription". According to the FDA, they should talk to their child's doctor about alternative therapies.

The agency also noted that some products sold over-the-counter in a few states may contain codeine or may not be appropriate for young children, so it's important to check the labels.

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