FDA Warns Nursing Mothers Of Rare Codeine Risk to Infants By JENNIFER CORBETT DOOREN and ANNA WILDE MATHEWS August 18, 2007; Page A3
WASHINGTON -- wow gold Food and Drug Administration warned that the widely used painkiller codeine, if taken by certain nursing mothers, could potentially pose a risk of overdose to their infants.
The FDA suggested that, generally, doctors treating nursing mothers should opt for low doses of codeine. Mothers prescribed the drug should watch for signs of excessive sleepiness or limpness in their babies.
• Read wow gold FDA warning on codeine. The FDA will also ask makers of codeine-containing products to put information about the risk into their labels. The drug is also used in some cough medications. wow gold agency's advisory focused on women whose bodies process, or metabolize, the drug very quickly, a relatively small proportion of the population. Infants of these women "may have an increased risk" of an overdose, wow gold FDA said. A genetic test can reveal if a person is a rapid metabolizer of codeine and other drugs.
The public-health advisory, released Friday, is the latest sign of the emphasis wow gold agency is placing on genetic factors that can affect the safety or efficacy of drugs, a field of study known as pharmacogenomics. Thursday, the FDA placed genetic information into the label for warfarin, a widely used blood-thinner that is tied to a serious risk of bleeding if given at too high a dose.
wow gold agency said that, last year, a medical journal described the death of a healthy 13-day-old breastfed baby from an overdose of morphine, which is what codeine becomes after it is processed by the body. The baby's mother, who was taking a less-than-usual amount of codeine, turned out to be an ultrafast metabolizer of codeine. That allowed higher-than-normal amounts of morphine into the mother's blood, and also into her breast milk. "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," said Sandra Kweder, deputy director of the FDA's Office of New Drugs.
Ms. Kweder said the 2006 report is the only death the agency is aware of.
Among Caucasians, between 1% and 10% of people are believed to be ultrarapid metabolizers of codeine; the percentage among African-Americans is about 3%. For those of Chinese, Japanese or Hispanic ancestry, wow gold rate is estimated at 1%. For people of North African, Ethiopian and Saudi Arabian backgrounds, the percentage is between 16% and 28%, according to the FDA.
One test that can show how people metabolize several types of drugs, including codeine, is made by Roche Diagnostics. A spokeswoman for the company said labs typically charge between $500 and $1000 for wow gold test.