FDA Drug Safety Communication on codeine pain
and cough medicines and tramadol pain medicines
FDA is restricting the use of codeine and tramadol medicines
in children. We are also recommending against using codeine and tramadol
medicines in breastfeeding mothers due to possible harm to their infants.
Codeine is approved to treat pain and cough, and tramadol is
approved to treat pain. These medicines carry serious risks, including slowed
or difficult breathing and death, which appear to be a greater risk in children
younger than 12 years, and should not be used in these children. These
medicines should also be limited in some older children. Single-ingredient
codeine and all tramadol-containing products are FDA-approved only for use in
adults. We are also recommending against the use of codeine and tramadol
medicines in breastfeeding mothers due to possible harm to their infants.
As a result, we are requiring several changes to the labels
of all prescription medicines containing these drugs. These new actions further
limit the use of these medicines beyond our 2013 restriction of codeine use in
children younger than 18 years to treat pain after surgery to remove the
tonsils and/or adenoids.
Read the full Drug Safety Communication
Use of Codeine and Tramadol
Products in Breastfeeding Women � Questions and Answers
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