The FDA urges healthcare providers and breastfeeding mothers to report side effects that occur while using codeine or tramadol to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.Ħ.Because most mothers will not know if they are ultra-rapid metabolizers, they will not know that using codeine or tramadol may place their babies at greater risk for an overdose. The FDA wants breastfeeding mothers or caregivers to watch closely for signs of problems in infants when the mothers are taking any opioid pain medicine, and especially when they are using codeine or tramadol for pain.The FDA issued a Drug Safety Communication regarding the strengthened warning to mothers (among other warnings) that breastfeeding is not recommended during treatment with codeine or tramadol due to the risk of serious adverse reactions in breastfed infants such as excess sleepiness, difficulty breastfeeding, and serious breathing problems that may result in death. What is FDA doing in response to this information related to women who are breastfeeding? In breastfeeding mothers, the ultra-rapid conversion of codeine to morphine and tramadol to M1 can result in high and unsafe levels of morphine and M1 in blood and breast milk.ĥ.However, tramadol and its metabolite M1 are also present in breast milk, and tramadol has the same risk as codeine with regard to ultra-rapid metabolism and the potential for life-threatening respiratory depression in an infant breastfeeding from a mother who is an ultra-rapid metabolizer. A review of the available medical literature for data regarding tramadol use during breastfeeding did not reveal any cases of adverse events. In our review of the medical literature for data regarding codeine use during breastfeeding, we found numerous cases of excess sleepiness and serious breathing problems, including one death, in infants of breastfeeding mothers who were taking codeine. What new information is FDA announcing about codeine and tramadol with respect to breastfeeding mothers? Reference: Gaedigk et el, Genet Med, 2017 PMID: 27388693Ĥ. Oceanian, Northern African, Middle Eastern, Ashkenazi Jews, Puerto Rican Ultra-rapid metabolizers (per 100 people) Table 1: Approximate number of CYP2D6 ultra-rapid metabolizers in different populations Population
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