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22 April 2017, 01:51 | Elizabeth Houston
On April 20, the FDA issued a consumer alert warning parents that codeine and tramadol, which are both opioids, can cause risky breathing problems in children.
The labels of all prescription medications containing codeine or tramadol will now restrict their use in children under 12 and recommend against their use in children between 12 and 18 years of age. The problem is that nursing mothers who use codeine or tramadol can pass risky levels of opioids to their infants through breastmilk. This new action further limits the use of these medications beyond the 2013 restriction of codeine use in children 18 years to treat pain after surgery to remove the tonsils and/or adenoids.
Codeine and tramadol are a type of narcotic medicine called opioid. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults.
This is especially concerning in children under 12 years of age and adolescents who are obese or have conditions that may increase the risk of breathing problems, like obstructive sleep apnea or lung disease.
Labels for both codeine and tramadol are being updated to include additional "Contraindications and Warnings".
On Thursday, FDA said that some children are at higher risk of harm from the medicines because they break down codeine and tramadol more rapidly than normal, which can cause dangerously high levels of the drugs in the blood.
"Maybe a little pain is better than the alternative", Cote said. The agency cited concerns about slowed or hard breathing or death, especially among younger children and infants in its decision to restrict the use of products containing these two drugs.
"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 healthcare providers and parents", explained Throckmorton. Tramadol will now also bear this warning in addition to the other new contraindications and warnings. Since some medicine contains narcotics like codeine and tramadol that are proven to be fatal to kids.
A review of medical literature for data regarding the use of codeine in nursing mothers found several cases of excess sleepiness and serious breathing problems in breastfed infants, including 1 reported death.
Conclusively, parents should actively check for any warning labels on medication that they plan to give to their children. Finally, FDA is adding a strengthened Warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants. They also can ask their doctor or pharmacist if a specific medication contains codeine or tramadol.
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