FDA Changes Safety Label for Pediatric Prescription Opioid Medication

FDA Changes Safety Label for Pediatric Prescription Opioid Medication

The label change also proceeds a pediatric restriction set previous year that required a contraindication to prescription codeine product labels. These changes include limiting the use of these agents to adults ≥18 years old, as well as the addition of new safety information regarding the risks of slowed or hard breathing, misuse, abuse, addiction, overdose, and death to the Boxed Warning. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

According to the agency, outside experts said that while some children's coughs require treatment, many get better on their own - including ones that are the result of respiratory infections. Common side effects of opioids include headache, dizziness and vomiting.

FDA Commissioner Scott Gottlieb, who has made battling the opioid epidemic a top priority, said in a statement Thursday that it is critical "to protect children from unnecessary exposure" to prescription cough medicines containing codeine or hydrocodone.

Products covered by Thursday's announcement included four with codeine, in combination with other agents such as chorpheniramine and promethazine, and five with hydrocodone along with other ingredients. "At the same time we're taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products", he said. Notably, the FDA advisory committees that have been responsible for assessing the suitability of utilizing opioids as treatment options for coughs and colds in pediatric populations have focused on two age groups: those 6 to 12, and those 12 to 18.

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So what's the advice for parents who may be using these medicines for their child already?

Some codeine cough medicines are available over the counter in a few states, FDA noted, saying it is also considering regulatory action for these products.

There's more about this issue at the American Academy of Pediatrics.

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