The U.S. Food and Drug Administration is tightening guidelines for codeine and tramadol use.
The FDA said Thursday children under age 12 should not use the medicines, both of which treat pain. The new warning further limits the agency's previous restriction of codeine use in children younger than age 18.
"These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children," the agency wrote in its safety announcement. "These medicines should also be limited in some older children. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults."
Additionally, the FDA recommended breastfeeding mothers not use codeine and tramadol medicines "due to possible harm to their infants."
As part of the new restrictions, the FDA said it is requiring several prescription label changes.
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