FDA strengthens warning against codeine and tramadol for children

FDA strengthens warning against codeine and tramadol for children

FDA strengthens warning against codeine and tramadol for children

Now, the US' FDA is restricting the use of codeine and tramadol medicines in children due to risks including slowed or hard breathing and death, "which appear to be a greater risk in children younger than 12 years".

On Thursday, the U.S. Food and Drug Administration warned that Parents shouldn't give their children medications containing the narcotics codeine or tramadol.

The FDA also warned nursing mothers who are taking the medications can pass unsafe levels of opioids to their babies through breast milk.

FDA statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs, Center for Drug Evaluation and Research, on new warnings about the use of codeine and tramadol in children & nursing mothers. Some children and adults break down codeine and tramadol into their active forms faster than other people.

The FDA is reminding healthcare professionals that tramadol and single-ingredient codeine medications are only FDA-approved for adult use. Additionally, the FDA reviewed adverse events reports submitted to the agency spanning from 1969 to 2015, and found 64 cases of serious breathing problems, including 24 deaths, associated with codeine-containing medicines in children younger than 18 years old.

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Since 2013, the FDA has issued several alerts regarding safety issues with the use of codeine and tramadol in children. The agency cited evidence that the drugs could cause dangerously slowed breathing in some children, which could lead to death. Both drugs will also carry warnings that children between the ages of 12 and 18 who are obese face an increased risk of breathing problems if they take the drugs. Apparently, narcotics such as codeine and tramadol can be fatal when used by children.

"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", said Throckmorton.

The new warnings did not further restrict over-the-counter medicines that contain codeine, such as popular types of cough syrup and medication marketed for cold and flu symptoms.

Regarding codeine use during breastfeeding, a literature search revealed numerous cases of respiratory depression and sedation, including one infant death, especially in mothers who have the CYP2D6 ultra-rapid metabolizer genotype. In addition, the Agency is considering more regulation surrounding OTC codeine products that are available in some states. The FDA urged parents to carefully read labels of nonprescription cough medicines to avoid codeine and to consult a doctor or pharmacist if needed.

Atlanta pediatrician Dr. Maia Walton said she rarely prescribes opioid pain medications to her patients.

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