Cough Syrup With Codeine or Hydrocodone Is Dangerous for Kids: FDA

The FDA took more steps Thursday to keep opioids out of children's medications, announcing changes to labels for nine types of prescription cough and cold medications containing codeine or hydrocodone, indicating that they should not be given to patients younger than 18.

Additionally, labels will also include updated safety information for use in adults, including an expanded boxed warning notifying about the risks of misuse, abuse, addiction, overdose, death, and slow or hard breathing that can result from exposure.

The decision to limit the prescription opioid cough and cold medicine availability for pediatric patients was based on extensive data review and advisory committee input. We know that any exposure to opioid drugs can lead to future addiction.

According to a statement from the agency, the safety labeling changes are meant to limit the use of these medications in children younger than 18 years old, as these products could be associated with risks.

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.

"It's commendable that the FDA is acting to expand safety use labeling not only for children and teens, but adults as well", said Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York City.

The FDA recommends OTC products, such as dextromethorphan, as well as prescription benzonatate products when cough treatment is necessary. Caregivers should also read labels on non-prescription cough and cold products.

But health officials say that shouldn't be a problem as most coughs don't need any treatment.

"It's critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone", he added.

Common adverse effects of opioid therapies include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache, according to the FDA. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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