FDA makes move to protect children, nursing moms from serious risks of some medicines
NASHVILLE, Tenn.--The Food and Drug Administration (FDA) has made some changes to the labeling of opioid medications when it comes to your children.
The move is an effort to "better protect children from serious risks" associated with codeine -found in many cough medicines both over the counter and prescription- and tramadol, which is found in many prescription medicines.
The FDA says some children who take the medicines can develop life-threatening respiratory depression and death due to metabolizing the medicines much faster than others. As a result, dangerously high levels of the active drug could be in their bodies.
Those most at risk are children under 12, obese adolescents, and those who have conditions that may increase the risk of breathing problems.
The risks don't stop there. Mothers who take these meds can pass it on to their nursing babies through breast milk.
The FDA says labels will now warn of the dangers for children age 12-18 and recommend against use by nursing mothers.
The medicines affected are as follows:
Medicines with codeine:
Butalbital, Acetaminopen, Caffeine, and Codeine phosphate
Fiorinal with codeine
Soma Compound with codeine
Tylenol with codeine
Promethazine with codeine (cough)
Prometh VC with codeine (cough)
Tuxarin ER (cough)
Generic products containing codeine
Medicines with Tramadol:
Generic Products containing tramadol
Medicines with Dihydrocodeine: