The FDA is restricting the use of codeine and tramadol medicines in children. In a Drug Safety Communication, the agency cited the serious risks these medicines pose to children.
The FDA notes that drugs containing codeine and tramadol may cause children to suffer from slowed or difficult breathing, and in some cases lead to death. Children younger than 12 years face the greatest risk from these medicines, however their use should be be limited in some older children as well.
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Additionally, the FDA is recommending that women who are breastfeeding should also avoid medicines with codeine and tramadol.
The FDA reviewed adverse event reports submitted from January 1969 to May 2015. They identified 64 cases of serious breathing problems, including 24 deaths, with the use of codeine-containing medicines in children younger than 18 years. They also identified nine cases of serious breathing problems, including three deaths, with the use of tramadol in children younger than 18 years. Most of the serious side effects occurred in children younger than 12 years.
The agency is updating the labels on codeine- and tramadol-containing drugs to include a contraindication, the FDA's highest warning. The contraindication indicates that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 years. The FDA is also updating the labels warning against the use of these medicines in children with certain conditions between the ages of 12 years and 18 years as well as breast-feeding mothers.