FDA changes label requirements for some children's medicines

baby coughing
(Photo: WBAY/file)
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(KWTX) The U.S. Food and Drug Administration is making major changes to labeling requirements for certain medicines aimed at children.

On Thursday, the FDA announced it is requiring the changes in order to limit the number of children using prescription opioid cough medicines and cold medicines containing codeine and hydrocodone.

According to the announcement, labeling for those medications is also being updated with additional safety warning for adult use notifying users about the risks of misuse, abuse, addiction, overdose, and death, along with slowed or difficult breathing.

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

Gottlieb also cited the ongoing epidemic of opioid addiction, and stressed the importance of reducing exposure to addictive drugs at a young age.

According to the FDA, labeling for adult-only use of prescription opioid cough and cold medicines that contain codeine or hydrocodone will also now include updated safety information. The new labeling will provide safety warnings on these products that are consistent with the labeling of other opioid-containing drug products, including both immediate-release and extended-release and long-acting opioid analgesics.

The FDA also says the new changes are " based on an extensive review of available data and expert advice shared at meetings to explore the pediatric use of opioid-containing cough and cold products."

Common side effects of extended opioid use include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache.

Parents whose children are currently prescribed cold or cough medication containing codeine or hydrocodone are encouraged to talk with their doctors about other treatment options.