FDA Wants to Revise Pregnancy Info on Drug LabelsMay 29, 2008 | Parker Waichman LLP
U.S. health officials just proposed changes aimed at proving better information on prescription drug labels about the risks they pose to pregnant and breast-feeding women. Today, there is little information indicated about how medicines may affect a fetus or breast-fed infant in many cases and physicians have long complained that available data is either not always present on drug labels or was presented in a confusing format. About six million pregnancies occur in the United States annually and pregnant women take an average of three to five prescription drugs during pregnancy, the Food and Drug Administration (FDA) said.
The proposal seeks to eliminate confusing categories now used on prescribing instructions for doctors to indicate the risk to a fetus, the FDA said. Under today’s lettering system, a category "A" drug means studies have not shown a higher risk of birth defects, while "X" means the drug should not be used during pregnancy. Other letters denote various levels of evidence for potential harm or a lack of data. Instead, future drug labels would carry three summaries with information about risks to the fetus, the effects of the disease on the mother and baby, and supporting data. Also, a lactation section would detail what is known about a drug's potential effects on a breast-fed infant.
Apparently, the FDA did recognize the challenges of current information in drug labels as far back as the 1990s and had been considering improvements since then. According to Sandra Kweder, deputy director of the FDA's Office of New Drugs, the agency heard concerns that the letter system "led to an inaccurate and overly simplified view" of risks. The new format has been designed to provide more complete information and be "practical and useful to clinicians and patients who are in the real world, trying to make some very difficult decisions," Kweder said.
Medicines a woman may take during pregnancy may treat pregnancy complications or chronic conditions such as asthma or depression. Doctors and patients must decide if treating a condition is worth the known or unknown risks of taking a drug during pregnancy, a difficult task given today’s confusing system that is lacking in clear and critical information.
Diana Zuckerman, president of the National Research Center for Women & Families, said the consumer group supported eliminating the letter categories, but stressed that drug labels "can't be very good as long as there is so little research on which medications are safe for pregnancy and nursing." Dr. Michael Katz, a senior vice president at the March of Dimes, said the group welcomed the plan, "It makes it clearer for everyone, including the lay people who might want to consult it.” Additional information has been developed in recent years about drugs' effects on a fetus; companies are more likely to seek the information from animal studies or registries of pregnant women who take their medicines, Katz said.
The FDA said it would take comments on the plan for 90 days. Once final, the revised label would appear on newly approved drugs. Older medicines would be phased in. The Pharmaceutical Research and Manufacturers of America, an industry group, is reviewing the proposal, spokesman Ken Johnson said.