Friday, Oct. 4, 2013
Amarillo doc asked to revise drug label info for women
By Eboni Graham
PROVIDED PHOTO Dr. Thomas Hale discusses his work through Hale Publishing - including publications, research and the Mommy Meds app - during a recent conference in Dallas.
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Thomas Hale, professor of pediatrics and founding director of the InfantRisk Center at Texas Tech University Health Sciences Center in Amarillo, hopes the Food and Drug Administration will put information on nursing safety on the package inserts included with over-the-counter medications.
For now, most drug labels contain a simple statement that cautions women against taking most OTC drugs while pregnant, Hale said.
“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.
An FDA committee recently invited Hale, who has more than 30 years of experience and has performed extensive research into the transfer of medications into breast milk, to give a presentation on developing new drug labels.
Hale’s idea for the new labels would replace the current “Nursing Mothers” section with a heading called “Lactation,” and would give more detailed information about a drug’s transfer to breast milk and potential to harm to a breast-fed baby.
The proposed changes are part of the FDA requiring drug makers to study how medications might affect breast-feeding and to better communicate that information to women and their doctors. The American Academy of Pediatrics, in consultation with the FDA, recently released a report that found most medications and vaccines are safe for nursing mothers and their babies.
Attempts to contact the FDA for comment Thursday were unsuccessful.
For now, Hale is developing a mobile app to help mothers make informed decisions about taking medications while they’re pregnant or nursing.
“We get calls from over 50 countries on everything from unusual syndromes to ingesting substances,” Hale said.
Taken from a database of information collected over the course of three to four years, the app pulls information on medications from a list of 1,500 prescriptions and 18,000 over-the-counter drugs.
Scheduled to launch this month, Hale said the new app will be available for iPhone and Android users.
“I think that would be very convenient if you had medicine that you didn’t know about,” said Disney Collier, mother of two sons. “You could just be able to scan it.”
Collier, who breast fed her 19-month-old and is nursing a 1-month-old, said although she’s familiar with which medications to take and what not to take, she still would check out the app.
“This app sounds like if it’s the weekend and you can’t really talk to your doctor, then that might be a good alternative,” she said.
“That might be something in the future that I’d check out for certain allergy medicines; that would probably be useful.”
According to Hale, common medications such as acetaminophen, ibuprofen and naproxen sodium are safe drugs to take during pregnancy and breast-feeding.
“Eighty percent of the drugs used in pediatrics are not cleared by the FDA,” Hale said. “But that’s changing, and now it’s required by law that drugmakers include pediatric study along with adult studies as well.”
For more information on Dr. Thomas Hale, his work or his new app, visit www.infantrisk.com.