FDA cautions about codeine use by nursing mothers

The US Food and Drug Administration has issued a warning regarding the potential risk of morphine overdose in nursing infants whose mothers are ultra-rapid metabolizers of the analgesic codeine. The guidance follows the death of a 13-day old breastfed infant from such an overdose. Subsequent testing revealed that morphine levels in the mother's breast milk were abnormally high, and confirmed the woman's status as an ultra-metabolizer of the drug.

The FDA said that nursing mothers have used codeine safely for many years, adding that it is generally considered the safest narcotic-based pain reliever for this group. However, the agency added that, in light of its review, it now requires manufacturers of the drug to make mothers aware of the potential risks of codeine ultra-metabolism in packaging, and has posted further information on its own web site.

Sandra Kweder, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, said: "our best advice to physicians prescribing codeine-containing products to nursing mothers is to prescribe the lowest dose needed for the shortest amount of time."