THE US Food and Drug Administration (FDA) has overnight announced new restrictions on the use of prescription codeine pain and cough medicines and tramadol pain medicines in children.
A new advisory confirms the medicines carry "serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years".
The FDA is also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their babies from taking the medications.
Actions include the addition of new "contraindication" warnings to the drug labels of codeine and tramadol, including a warning that codeine should not be used to treat pain or cough in children under 12, and that tramadol should not be used in children younger than 18 years to treat pain after surgery to remove tonsils and/or adenoids.
For details see www.fda.gov.
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