FDA Proposes New Drug Labels for Pregnant Women
WEDNESDAY May 28, 2008 -- U.S. health officials proposed Wednesday changes to the labels on prescription drugs that would detail potential health effects for pregnant and breast-feeding women, their fetuses or their newborns.
If enacted, the new system, proposed by the U.S. Food and Drug Administration, would provide doctors and pharmacists with more comprehensive information to guide them in their prescribing practices.
"The most important tool the FDA has to carry out its mission to protect and promote the health of every single American is the legal authority we've been given to determine the content and the format of labeling," FDA Commissioner Dr. Andrew C. von Eschenbach said during a teleconference.
The proposed system would replace the current system that relies on letter designations to describe the risks of a drug when taken during pregnancy or breast-feeding. This system was deemed confusing and incomplete.
"The system of letter categories has led to an inaccurate and overly simplified view of prescribing in pregnancy," Dr. Sandra Kweder, deputy director of FDA's Office of New Drugs, Center for Drug Evaluation and Research, said during the teleconference. "This system also makes it very difficult to update labeling as new information becomes available," she added.
There are about six million pregnancies in the United States every year, and pregnant women take an average of three to five prescription drugs during pregnancy. Also, women with pre-existing medical conditions, such as asthma or high blood pressure, may need to use prescription drugs to treat those conditions during pregnancy, the FDA noted.
Under the new proposal, drug labeling would explain the potential benefits and risks for the mother, her fetus or her new baby, and how these risks change over the course of pregnancy, Kweder said.
New drug labels would include three sections devoted to pregnancy and breast-feeding. The first section, called the "Fetal Risk Summary," would describe what's known about the effects of a drug on the fetus and whether the risk is based on results of animal studies or human studies.
The second section, called "Clinical Considerations," would include information about effects associated with the drug if it were taken before a woman knows she is pregnant. This section would also outline risks of the disease to the mother and baby, dosing information and how to address complications.
The final section, called "Data," would describe in detail the available information about the drug's use in humans and animals studies used in developing the "Fetal Risk Summary."
The breast-feeding section of the label would use the same format as the pregnancy section and provide information about using the drug while nursing, Kweder said.
The FDA began work on redesigning labels of prescription drugs' effects during pregnancy and breast-feeding in 1997. The proposed changes announced Wednesday will undergo a review process, with the agency receiving comments from various stakeholders. Once that review has been completed, the FDA will incorporate the comments and come up with a final version of the labels. This process could take up to one year to finish, officials said.
Once the rule takes effect, new drugs would have to conform immediately to the revised labeling standard, Kweder said. For older drugs, the label requirements would be phased in over time. It will take several years for all drugs to comply with the new label standard, she said.
For more on prescription drugs and pregnancy, visit the U.S. Department of Health & Human Services.
Posted: May 2008