ordered new labeling that warns against giving codeine and tramadol to children younger than 12.
The Food and Drug Administration on Thursday sharply ratcheted up its warnings about giving children prescription medicines with codeine and tramadol, saying the drugs could cause severe breathing problems and death.
The agency said it would require manufacturers to make label changes to warn that the drugs should not be given to anyone younger than 12 and should be restricted in older children. The FDA also warned breast-feeding mothers to avoid using the medicines.
Codeine and tramadol are opioid medications used to treat pain. Codeine also is used in cough syrup and cold remedies and sometimes is combined with other medications, such as acetaminophen. Tramadol is approved only to treat pain in adults, but data show it is being used by children and adolescents, the FDA said.
Douglas Throckmorton, a top official at the FDA’s Center for Drug Evaluation and Research, said in a telephone briefing for reporters that the safety hazards are the result of the “unique way” these medications are broken down in the bodies of some children and adults.
He said that “ultra-rapid metabolizers” process the drugs much faster than usual, resulting in dangerously high levels that can depress breathing and lead to death.
The agency said that a safety review of adverse events reports submitted to the FDA from January 1969 to May 2015 identified 64 cases of serious breathing problems, including 24 deaths, involving codeine-containing medicines taken by children younger than 18.
Between January 1969 and March 2016, there were nine cases of breathing problems, including three deaths, involving the use of tramadol by children younger than 18.
The majority of serious side effects occurred in children younger than 12, sometimes after a single dose, the FDA said. The agency also found, in a review of the medical literature, a report of an infant who died after being exposed to codeine through breastfeeding.
In 2013, the agency restricted use of codeine in children to treat pain after surgery to have tonsils and adenoids removed. Two years later, it issued two safety warnings about the drugs.
The agency on Thursday ordered several alterations in labels to underscore the risks of the drugs to children. Besides a change saying that the drugs shouldn’t be used by children younger than 12, the mandated changes include a new warning
The agency is requiring new labels that warn against use of the common medications by children younger than 12.
that tramadol shouldn’t be used by children younger than 18 for post-surgical pain after the removal of tonsils and adenoids. Another new warning on codeine and tramadol labels will recommend against their use in adolescents between 12 and 18 who are obese or have other conditions that might affect their breathing, such as lung disease or sleep apnea.
FDA officials also urged parents to check the ingredients of overthe-counter medications and to be extremely careful of giving children any that contain codeine.