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The US drug regulator has issued restrictions on codeine and tramadol in children’s medicines.
The Food and Drug Administration (FDA) has advised the risk of breathing difficulties and death associated with the drugs means they should not be used at all in patients under the age of 12 years.
A review of adverse event reports spanning several decades submitted to the FDA identified 64 cases of serious breathing problems, including 24 deaths, with codeine-containing medicines in children under 18 years and 9 cases of serious breathing problems, including 3 deaths, with the use of tramadol.
Under the new recommendations, single-ingredient codeine and all tramadol-containing products are only approved for use in adults, the FDA says.
The regulator has recommended against the use of codeine and tramadol medicines in breastfeeding mothers to prevent possible harm in infants, including excess sleepiness, difficulty breastfeeding, or serious breathing problems.
It follows rule changes in 2013 that advised against the use of codeine use in patients under the age of 18 to treat pain after surgery to remove tonsils or adenoids after reports of death.
An advisory committee had been reviewing the evidence since 2015 when the FDA issued a warning about serious breathing problems in some children who appeared to be ultra-metabolisers of the drugs converting them to their active form more rapidly than usual.
A warning has also been issued that neither drug should be used in teenagers who are obese or who have respiratory conditions, such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.
