FDA Proposes New Drug Labeling for Women

May 28, 2008— -- 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.

It is not the first time Public Citizen has taken aim at the labeling of drugs for women. In an April 2005 letter to the FDA, Public Citizen criticized the lack of information on drug labels, calling information for nursing mothers "rarely helpful."

Wolfe said the ideal approach would have been to apply the existing rating system used with regard to pregnancy -- with a few tweaks -- to lactation as well.

The system FDA is proposing, he said, could provide breast-feeding mothers with more information but may hurt efforts to keep pregnant women informed.

"For lactation, since there weren't any categories before, it may be a step forward," he said. "But it may be a step backward for pregnancy."

Enough Information?

The proposed guidelines may be complicated by the fact that, for many drugs, there is little research available on their potential effect on pregnant and nursing women or their children. Since testing drugs on pregnant and nursing women poses huge ethical questions, most of the data available is from animal studies, research that goes only so far when it comes to determining possible effects on humans.

The form in which the new recommendations will go into effect will be determined largely over the next 90 days, during which the FDA will accept comments from medical professionals and the public. The agency said it expects the rule to go into effect "no earlier than June 30, 2010."

But for some, the changes cannot come soon enough.

"As a pediatrician and mother, it is frustrating to make medication decisions with the current risk categories that are vague at best," said Dr. Tasneem Bhatia of the Atlanta Center for Holistic and Integrative Medicine.

"Women today are already concerned with the risks of many environmental toxins -- vaccines, antibiotics, contaminated food, et cetera. It would be helpful to take medications out of this list."

Kate Barrett contributed to this report.