FDA warns against cough medicine for kids with codeine, hydrocodone


Do you reach for the cough syrup when your little one catches a cold? Make sure it doesn’t include codeine or hydrocodone, because the Food and Drug Administration says the opioid ingredients could pose some serious safety risks

» RELATED: Opioids now kill more Americans than guns or breast cancer, CDC says

The organization announced Thursday that it is now requiring manufacturers to change the labels on cough and cold medicines containing these ingredients to prevent children under 18 from using them. 

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The FDA is also asking companies to add new safety warning labels on medicines for adults, including an expanded boxed warning, which describes the risks of taking those that include codeine and hydrocodone. 

Common side effects of opioid use include headache, vomiting, dizziness, breathing difficulties and even death. 

»RELATED: 5 ways to to talk to your young child about the opioid epidemic

“Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children. We know that any exposure to opioid drugs can lead to future addiction. 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,” FDA commissioner Scott Gottlieb said in a statement.

In September, the FDA met with the Pediatric Advisory Committee to determine the dangers associated with using opioids in children’s cough medicine. They believe the risks outweigh the benefits. And while they say some kids’ cough require treatment, symptoms usually subside on their own. 

“It’s critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone,” Gottlieb said. “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.”

» RELATED: FDA panel: Teens risk breathing trouble from codeine cough syrup

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