Most Medications OK During Breast-Feeding
Mothers may be able to take needed drugs while nursing
By Brenda Goodman
MONDAY, Aug. 26 (HealthDay News) -- Most breast-feeding moms can safely take the medications and vaccines they need, without fear they'll harm a nursing infant, according to a new report from a leading group of U.S. pediatricians.
The report, from the American Academy of Pediatrics in consultation with the U.S. Food and Drug Administration, describes proposed changes to drug labels. The new labels would replace the current "Nursing Mothers" section with a heading called "Lactation," which would give much more detailed information about a drug's transfer to breast milk and potential to harm a breast-fed baby.
The proposed changes are part of a push by the FDA to require drug makers to study how medications may affect breast-feeding and to better communicate that information to women and their doctors.
"Because we know that breast-feeding has both developmental and health benefits for the mom and the baby, we are encouraging research in this area so physicians can make informed decisions about how best to treat their patients," said study author Dr. Hari Cheryl Sachs, a pediatrician and leader of the pediatric and maternal health team within the FDA's Center for Drug Evaluation and Research.
Breast-feeding advocates cheered the new report, published online Aug. 26 in the journal Pediatrics.
"The general takeaway message -- that most drugs are compatible with breast-feeding, that mothers don't have to wean to take drugs and that the labels should accurately reflect the science -- is really great news and progress for breast-feeding mothers," said Diana West, a lactation consultant and spokesperson for La Leche League International.
Most drug labels now have a blanket legal statement that cautions against taking nearly any medication while pregnant, something that irks Thomas Hale, director of the InfantRisk Center at Texas Tech University Health Sciences Center in Lubbock. Hale has been doing research on the transfer of medications to breast milk for more than 30 years. He also is the author of the book Medications and Mothers' Milk, which has become something of a bible on the subject.
"If you pick up any package insert, you see the same language: 'There are no data available on this drug. Do not use in breast-feeding mothers,'" Hale said.
He said he was recently invited to give a presentation to the FDA committee developing the new drug labels. The first slide he put up was a picture of the blanket caution from the label of the antidepressant drug Zoloft (sertraline).
But in the case of Zoloft and many other drugs, he said, that's not the whole story.
Hale said 60 breast-feeding mothers who were taking Zoloft and their babies have been studied. "We knew exactly how much got into milk and it was almost nothing," he said. And that's just one example.