07/27/17 RC -- Codeine and Tramadol Products Restricted to Adults
The FDA has issued an update on safety issues regarding codeine and tramadol use in children. They now list use of these two drugs as contraindicated in children under 12 years old for treating cough and pain. In some other specific situations, they are not recommended for use in children under 18 years old. The concern here is rapid CYP-2D6 metabolizers will quickly convert codeine to morphine, and tramadol to an active metabolite, causing high blood concentrations and possibly respiratory depression and even death. On July 25th, the P and T Committee approved restricting use of codeine and tramadol (including combination products) to only adults 18 years and older. This restriction would include combination products such as acetaminophen with codeine, aspirin with codeine, Fiorinal with codeine, promethazine products with codeine, other cough/cold products with codeine, and for tramadol, Ultracet. Contact drug information with questions.
The FDA also stated that these two drugs are not recommended for use in breastfeeding mothers due to the risk of the same type of serious reactions in the breastfed infant. We will be consulting with the OB physicians in the near future to determine if we should implement a specific policy with these two drugs in breastfeeding.