Rare Side-Effect of Codeine in Nursing Mothers

FDA is alerting healthcare professionals about a very rare but serious side effect that can affect the babies of nursing mothers who are taking drugs that contain codeine. The problem affects mothers who are “ultra-rapid metabolizers” of codeine. Ultra-rapid metabolizers have a specific genotype that causes them to convert codeine to its active metabolite, morphine, more rapidly and completely than other people. This can result in the mother having unusually high morphine levels in her serum and breast milk, and this can put her nursing infant at risk of morphine overdose. A recent report in the literature described a healthy, 13-day-old breast-feeding baby who died of a morphine overdose. His mother was taking codeine at less than the usual analgesic dose. The prevalence of the ultra-rapid metabolizers of codeine varies for different populations. Among Caucasians, the figure is about 1 to 10 percent. Among African-Americans, about 3 percent are ultra-rapid metabolizers of codeine, and among Asians and Hispanics, about 1 percent. The highest prevalence is among some groups of North Africans, Ethiopians and Saudis, where it can be as high as 28 percent. It is important to note that nursing mothers have used codeine safely for many years. Many women are sent home after having a baby with analgesics such as acetaminophen with codeine to relieve episiotomy pain or abdominal cramping and many of these women are also breast feeding. Despite this widespread use, FDA was able to …
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