FDA Proposes New Drug Labeling for Women

Drugs prescribed to women may soon require new labels outlining special potential health effects for pregnant and nursing women.

A recommendation proposed by the U.S. Food and Drug Administration on Wednesday would change the current labeling system on the literature that accompanies medications, used chiefly by doctors and pharmacists but often available to patients. Some have criticized the system -- which places a drug in one of five risk categories, A, B, C, D or X -- calling it confusing.

Under the FDA's proposed system, the new label will be broken into the categories pregnancy and lactation. The pregnancy section would outline any known risks a given drug may pose to a fetus, while the lactation section would list any known details about "the drug's impact on milk production, what is known about the presence of the drug in human milk, and the effects on the breast-fed child."

"It's a population that has very, very special needs," said FDA Commissioner Dr. Andrew C. von Eschenbach during a Wednesday press conference.

"We're all well aware that not everyone likes change, and we're going to be looking at a public commentary period to get further information before we finalize this rule," he added. "But what we must do is address the needs of the patients we're here to serve."

A number of doctors said they believed the new labeling would be a boon for pregnant and lactating women, many of whom take multiple prescriptions; indeed, according to the FDA, the average pregnant woman takes three to five prescription medications.

"I have never found the current letter categorization very useful at all," said Dr. Goutham Rao, associate professor of pediatrics at the University of Pittsburgh School of Medicine. "Very few drugs carry an 'X' rating or an 'A' rating, leaving physicians wondering whether a prescription drug is safe or not, and what to tell patients."

"As a pediatrician, I frequently am asked about the safety of various medications by mothers and mothers to be," said Dr. Phil Fischer, medical director at the Mayo Clinic's Mayo Eugenio Litta Children's Hospital in Rochester, Minn. "The new FDA rules should help ensure that understandable information is readily available to physicians and to patients and families."

And breast-feeding experts noted the new guidelines may help reduce the chances that a woman will cut back on breast-feeding out of fear of hurting her baby, as well as protecting infants from exposure to certain medications.

"Current guidance offered by the FDA and [the Physicians' Drug Reference] are either not helpful or often incorrect, leading patients and practitioners to make a wrongful decision to wean or temporarily stop breast-feeding," said Dr. Lori Feldman-Winter at the America Academy of Pediatrics' section on breast-feeding.

But others said the proposed labeling system is not a perfect alternative for the current system.

"Given that most women don't get information on these medications other than from their doctors, the clearer the categories that the doctor has to translate to the patient the better," said Dr. Sidney Wolfe, director of the Washington, D.C.-based consumer advocacy group Public Citizen.

"They claim [the format of the information] is more accurate, but I think it will wind up being less accurate," he said.

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