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22 April 2017, 01:45 | Audrey Hill
USA regulators are strengthening warnings about the dangers of two types of powerful opioid painkillers, codeine and tramadol, due to risks of slowed breathing and death.
Medicines containing codeine and another narcotic, tramadol, will now require a label indicating that they should not be used by children under 12.
The FDA has issued a drug safety communication regarding new restrictions for the use of codeine and tramadol medications in children and nursing mothers. Kids younger than 18 shouldn't take tramadol to treat pain after surgery to remove the tonsils (tonsillectomy) or adenoids (adenoidectomy).
In addition, labeling for tramadol-containing products will get a contraindication for post-operative pain management in children up to age 18 years of age who have undergone the removal of the tonsils and/or adenoids, which is already in labeling for codeine products.
"It's very hard to determine which child or mother has this risk, so that's why we've taken this action today", Dr. Douglas Throckmorton, deputy center director for regulatory programs at the FDA's Center for Drug Evaluation and Research, said in a media briefing Thursday.
In the body, opioid painkillers and cough medicines are broken down into morphine.
The FDA is reminding healthcare professionals that tramadol and single-ingredient codeine medications are only FDA-approved for adult use.
The FDA also warns against using the drugs in those between 12 and 18 who are obese or have breathing problems such as sleep apnea or lung disease.
Warning labels on medications with codeine or tramadol will be strengthened to reflect these potential dangers, the FDA said in a statement. 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.
Now the Food and Drug Administration says children under 12 should not be given prescription medicines containing the drugs.
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.
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. According to the FDA's public label database, more than 100 medications containing codeine are approved for sale without a prescription in the U.S.
"These medicines should also be limited in some older children". The FDA is also considering other regulations that would apply to over-the-counter codeine products.
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