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Health

Nursing moms get FDA warning

Codeine can pose risks for breast-fed babies.

By DAVID BROWN, Washington Post
Published August 18, 2007

WASHINGTON - The Food and Drug Administration warned nursing mothers who are taking the painkiller codeine to be vigilant for unusual drowsiness or other signs of overdose in their babies, because a significant fraction of women carry a gene that leads to high concentrations of narcotic substances in their breast milk.

Friday's warning is not meant to discourage women who are prescribed codeine from breast-feeding. But it should spur them to contact their doctors if they or their babies seem overly sleepy while taking usual doses of the painkiller, an agency official said.

"If you as a mom are experiencing side effects, you should absolutely be watching your baby for the same kind of things," said Sandra Kweder, a physician and a deputy director in the FDA's Center for Drug Evaluation and Research.

Codeine is frequently prescribed for the pain of an episiotomy or a Caesarean section because it is safe, can be taken in pill form and acts for only a short period.

In the body, codeine is transformed into morphine. People who are "ultrarapid metabolizers" of the drug do this very quickly and more completely than others.

The morphine is excreted into breast milk in amounts that can cause limpness, excessive sleepiness, feeding difficulties and breathing problems in newborns.

If a nursing mother taking the drug notices those symptoms, she should contact a physician immediately or go to an emergency room, Kweder said.

Last year, a 13-day-old baby in Toronto died of a morphine overdose that was traceable directly to the mother's ultrarapid metabolism of codeine. That is the only known death from the condition.

As much as 10 percent of whites, 3 percent of blacks and 1 percent of Hispanics and Asians carry the ultrametabolizing gene variant. Between 16 and 28 percent of North Africans, Ethiopians and Saudis carry it, FDA officials said.

Friday's advisory was the second time this week the FDA discussed the role of genes in the risk for adverse side effects from drugs.

On Thursday, the agency warned physicians that some people taking the blood-thinner warfarin may be unusually sensitive to its effects or build up higher-than-expected concentrations of it in their bloodstreams, because of variations in two genes.

Fast Facts:

Labs to stay open

The Food and Drug Administration canceled plans Friday to close more than half of its field laboratories.

The proposed closures, part of a reorganization of the agency's field operations, previously had been suspended to await recommendations from a presidential panel about how to better guarantee the safety of imported food and other products.

Congress has been investigating the plan, including whether it would give to private companies some food safety work now performed by government employees. Lawmakers also had introduced legislation to block the closures.

[Last modified August 18, 2007, 01:16:38]