The Food & Drug Administration announced on Thursday that they will be strengthening the requirements for drug labels for codeine and tramadol to protect children.
Since it's almost impossible to identify the "ultrarapid metabolizers" or who may be especially sensitive or at higher risk of adverse events from the said opioid medications, the FDA now calls for stringent labeling requirements for manufacturers of codeine- or tramadol-containing drugs.
Among the updates are contraindications for use of codeine or tramadol in all children younger than 12 years, warnings about their use in children 12-18 years of age with certain medical conditions, and a stronger warning recommending against their use in nursing mothers. Drugs containing codeine already carry a black-box warning against using it to treat pain in children who have their tonsils removed.
As part of the new restrictions, the FDA said it is requiring several prescription label changes.
The FDA is reminding healthcare professionals that tramadol and single-ingredient codeine medications are only FDA-approved for adult use.
The agency also warned against using the drugs in young people between 12 and 18 who are obese or have breathing problems such as sleep apnea or lung disease. Tramadol is not approved for any uses in children, but it is commonly prescribed off-label to children anyway. Apparently, children's bodies break down such narcotics faster than adults do which results in a dangerously high level of drug in their bodies, hence it was concluded that codeine and tramadol can be fatal to kids. Codeine also is used in cough syrup and cold remedies and sometimes is combined with other medications, such as acetaminophen.
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The agency listed 15 medicines affected by the action, plus all of their generics, which included J&J's Tylenol with codeine and Vertical's tramadol med ConZip.
Narcotics such as codeine and tramadol are not only fatal to kids under 12 years of age, but also have negative effects on nursing mothers, a report by CBS News suggests.
Almost 1.9 million kids aged 18 or younger received a prescription for a codeine-containing medication in 2014, and almost 167,000 were prescribed a medication containing tramadol, the FDA said. After several deaths were reported, the American Academy of Pediatrics warned parents against giving codeine to children previous year.
"We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents". They also can ask their doctor or pharmacist if a specific medication contains codeine or tramadol.
Conclusively, parents should actively check for any warning labels on medication that they plan to give to their children.