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20 April 2017, 09:42 | Todd Saunders
These medicines can cause life-threatening breathing problems in children.
The FDA is warning that children younger than 12 shouldn't take codeine products to treat pain or cough or tramadol to treat pain.
Finally, the FDA said that these drugs should not be used in children 12 to 18 who are obese, suffer from obstructive sleep apnea or have a weakened respiratory system, as they can increase the chances of unsafe breathing problems.
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.
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.
Use of both codeine to treat coughs and tramadol to treat pain are now both contraindicated in young children under the age of 12, said the FDA in a statement. The risks factors can increase their chances of serious breathing problems, according to the FDA.
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Unlike codeine, tramadol wasn't FDA-approved for pediatric patients; however, in September 2015, the agency noted it was likely being used off-label in children.
Tramadol is available only for adults and by prescription to treat pain. FDA officials are also considering additional regulatory actions for over-the-counter codeine products, as well as an FDA Advisory Committee meeting to address the role of prescription opioid cough-and-cold medicines to treat cough in children.
"Maybe a little pain is better than the alternative", Cote said. They also can ask their doctor or pharmacist if a specific medication contains codeine or tramadol. Even in older children who have colds, coughs are generally mild and go away in a few days, so they may not need to take any medicine.
Parents should carefully read drug labels to make sure medications don't contain either opioid, the agency stressed.
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