FDA takes another look at prescription warnings

Agency seeks to clarify notes for pregnant or nursing women

May 29, 2008|By Jonathan D. Rockoff | Jonathan D. Rockoff,Sun reporter

WASHINGTON - Federal health officials proposed yesterday streamlining prescription drug warnings for women who are pregnant or nursing, to make it easier for physicians and patients to determine whether it's safe to take the medicines.

The Food and Drug Administration wants to replace confusing language in warnings with concise statements about the potential risks a drug poses if taken during pregnancy or while nursing.

"What we are looking for is to provide information in a way that is most useful and effective," said Dr. Andrew C. von Eschenbach, commissioner of the FDA.

The agency has been pushing to simplify drug warnings to reduce medication errors.

Women often enter pregnancy with reflux, depression or other conditions that require medication, or they develop illnesses that would benefit from antibiotics or other drugs. But the drugs can also pose risks for the women, their fetuses and their babies.

Drugs have contained pregnancy-related warnings since 1979, but doctors found the labels confusing because they divided warnings into five categories, depending largely on the quality of the evidence.

In addition, FDA officials said, drug makers have failed to update the labels.

"It's an antiquated system," said Dr. Lilly Hunter, an obstetrician-gynecologist at Greater Baltimore Medical Center, who found the warnings too vague to provide much help in deciding whether to prescribe. "What would be more helpful is a specific description of the risks."

Under the 136-page proposal, the FDA would scrap the existing categories. The warnings would, instead, summarize potential risks to the mother, fetus or baby. The label would also address the benefits of proceeding with treatment and how to deal with side effects.

"We think it is high time to get this accomplished," said Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs. The public has 90 days to comment. FDA officials hope to finalize the new rules within six months.

The changes would affect more than 5,000 products. New drugs or drugs getting a revised label would be required to adopt the new format immediately. Manufacturers would have as much as five years to incorporate the changes for existing drugs.

Amy Allina, program director of the National Women's Health Network, an interest group, expressed concern that drug makers would try to ignore evidence of negative side effects in revising the warnings. "The FDA is going to have to be proactive," she said.

Dr. Carla Weisman, an obstetrician-gynecologist at Sinai Hospital, questioned the usefulness of the changes because doctors have already figured out what advice to give patients regarding prescription drugs. "It may be a whole lot of noise about nothing," she said, "but it is true the current system is very confusing."

jonathan.rockoff@baltsun.com

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