FDA Warns Breast-Feeding Women Taking Codeine About Possible Overdose Risk For Infants

Main Category: Women's Health / Gynecology
Also Included In: Regulatory Affairs / Drug Approvals;  Pediatrics / Children's Health
Article Date: 22 Aug 2007 - 3:00 PDT

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FDA on Friday issued an alert that warns women who are breast-feeding and taking codeine about a possible risk of overdose for their infants, the Wall Street Journal reports (Corbett Dooren/Wilde Mathews, Wall Street Journal, 8/18). Codeine frequently is prescribed to women after giving birth for pain associated with episiotomies or caesarean sections, the Washington Post reports (Brown, Washington Post, 8/18). In addition, codeine is a common ingredient in some forms of Tylenol and nonprescription cough syrups, the Los Angeles Times reports (Lauer, Los Angeles Times, 8/18).

According to the Journal, some people are "ultra-rapid metabolizers" of codeine, which transforms into morphine in the body, causing higher-than-normal amounts of the drug to enter the bloodstream and breastmilk. A medical journal last year reported that a 13-day-old infant died after a morphine overdose, according to FDA. The infant's mother was taking a less-than-usual dose of codeine but was a fast metabolizer of the drug, the Journal reports. The infant's death is the only one of which the agency is aware (Wall Street Journal, 8/18).

Recommendations
According to the Post, the warning is not intended to discourage women from breast-feeding but rather to encourage them to monitor their infants for signs of overdose (Washington Post, 8/18). Signs of overdose for infants include sleeping for long periods of time, difficulty breast-feeding, constipation, breathing problems and limpness in the arms or legs. Marcia Buck, a clinical associate professor at the University of Virginia Medical Center, said women who are breast-feeding should maintain a "very low threshold" in determining whether to seek medical attention if they notice such symptoms in their infants.

Sandra Kweder, FDA's deputy director of the Office of New Drugs, said the agency's "best advice to physicians prescribing codeine-containing products to nursing mothers is to prescribe the lowest dose needed for the shortest amount of time" (Los Angeles Times, 8/18). FDA also recommended that physicians closely monitor breast-feeding women taking codeine and their infants for signs of possible overdose. In addition, the agency asked companies that make products containing codeine to include on product labels information about possible risks to breast-feeding women and their infants (AP/Baltimore Sun, 8/18).

FDA did not recommend that all women who are breast-feeding be tested to determine whether they are ultra-rapid metabolizers prior to taking codeine because there is no evidence to indicate that such a strategy would reduce complications (Washington Post, 8/18). Between 1% and 10% of whites, 3% of blacks and 1% of people with Hispanic, Chinese or Japanese ancestry are ultra-rapid metabolizers of codeine, the Journal reports. According to FDA, about 16% to 28% of people with North African, Ethiopian and Saudi dissent are ultra-rapid metabolizers. Labs usually charge between $500 and $1,000 for a Roche Diagnostics test that can determine how people metabolize several drugs, including codeine, according to a Roche spokesperson (Wall Street Journal, 8/18).

FDA's alert is online on its Web site.

CBS' "Evening News" on Friday reported on the warning. The segment includes comments from Robin Kalish, an ob-gyn at New York-Presbyterian Hospital (LaPook, "Evening News," CBS, 8/17). Video of the segment and expanded CBS News coverage are available online.

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