Dr. Hale on Revising Drug Label Info for Women

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.