Noticias:
AAP News Vol. 28 No. 8 August 2007, p. 2007274
© 2007 American Academy of Pediatrics
FDA warns of codeine's side effects in breastfed infants.
The Food and Drug Administration (FDA) is concerned that nursing infants may be at increased risk of morphine overdose if their mothers are taking codeine and are ultra-rapid metabolizers of codeine.
The public health advisory has resulted from FDA review of all available information after Lancet reported a study on a 13-day-old breastfed infant who died from morphine overdose (Koren et al. Lancet. 2006;368:704). The morphine levels in the mother's milk were abnormally high after taking small doses of codeine to treat episiotomy pain. A genetic test showed that the mother was an ultra-rapid metabolizer of codeine. Ultra-rapid metabolizers have higher-than-normal levels of morphine in their blood and breast milk after taking codeine.
Physicians should advise nursing mothers taking codeine to look for signs of overdose in babies, including increased sleepiness, difficulty breastfeeding, breathing difficulties or limpness.
An FDA-cleared test to check for ultra-rapid metabolism is available, but only offers limited information and may not correctly predict if a mother's breast milk will have too much morphine if she uses codeine to treat pain.
FDA is encouraging physicians to:
- prescribe the lowest dose of codeine-containing products to nursing mothers for the shortest amount of time;
- be aware of the risks to the infant when codeine is used by a nursing mother who is an ultra-rapid metabolizer;
- closely monitor nursing mothers and their babies when codeine is used, since in most cases, it is unknown if someone is an ultra-rapid codeine metabolizer; consider other options for relieving pain or persistent cough for nursing mothers known to be or suspected to be an ultra-rapid metabolizer of codeine; and
- use codeine only as directed for the shortest time possible and switch to use of an appropriate nonprescription medicine that does not contain codeine when pain improves.
FDA is requiring manufacturers of prescription codeine medicines to include information about codeine ultra-rapid metabolism in drug package insert information and asking physicians to report adverse events to MedWatch. For more information, visit www.fda.gov/cder/drug/infopage/codeine/default.htm.
Dr. William Macias PEDIATRA
