The stir The Food and Drug Administration (FDA) is advising new mothers who have trouble breast-feeding to steer clear of domperidone, which may stimulate milk production, saying the pill form of the drug poses "unknown risks." The pill, sold overseas but not approved for U.S. sale, is available via the Internet. On June 7 the FDA issued warning letters to pharmacies that sell the drug and directed FDA workers to look out for imports.
The backlash Some new moms and breast-feeding experts are challenging the FDA's action and questioning the agency's motives. Web sites for mothers were inundated last week with postings protesting the warnings. "I went berserk when I heard this," said Deborah Ringel, a Washington mother of three, after defending the drug on the DC Urban Mom Web site. "People use this drug when nothing else works. The FDA is preventing people from breast-feeding with this."
Some suggested that the FDA's action was tied to a larger political fight over the importation of drugs.
"This warning from the FDA has nothing to do with its safety," wrote Thomas Hale, a nationally recognized lactation expert and pediatrics professor at Texas Tech University in Lubbock. "It's all about the importation of drugs from Canada and control by this federal agency. . . . The reality is that I still believe domperidone is the safest product we can use for stimulating milk production."
The response FDA officials denied political motives and stood firm, citing case studies that link the intravenous form of the drug to cardiac arrest and death; the data are unclear, says the agency, about the pill, which carries a lower dose. "Dr. Hale may believe this product is safe, but FDA makes its determination of safety based upon review of data and not on individual beliefs," said Susan Allen, associate director of scientific and medical affairs at the FDA Center for Drug Evaluation and Research.
The upshot Some moms are unswayed. "For me, this drug has been a tremendous help," said Kelly Curran, who has taken it for five months. "We tried everything else first . . . and I'm still taking it."
-- Rebecca Adams