FDA warns against giving kids certain cough and cold medicines

12 Enero, 2018, 06:12 | Author: Earnest Bishop

The label changes, which will pertain to medicines containing codeine or hydrocodone, will also include safety information for adult use.

The US Food and Drug Administration (FDA) has announced safety labeling changes that will limit the availability of prescription opioid cough and cold medicines for patients younger than 18 years old.

The revised safety warnings on these products will be consistent with the labeling of other opioid-containing drug products, such as immediate-release opioid analgesics and extended-release and long-acting opioid analgesics, according to the FDA. 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.

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The new requirements build on previous restrictions enacted by the agency last year, when the FDA required the addition of a contraindication warning to the labeling, to warn against use in children younger than 12 years old due to risk of ultra-rapid metabolism in certain patients. For those children in whom cough treatment is necessary, alternative medicines are available.

"It's become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don't justify their use in this vulnerable population", he said. While today's action was meant to address prescription opioid cough/cold medications, the FDA is considering regulatory action for these OTC products as well. Experts noted that most pediatric cough symptoms that are caused by a cold or upper respiratory do not typically require treatment with these products.

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