FDA proposes new pregnancy labels for medicines
WASHINGTON (Reuters) - U.S. health officials proposed changes on Wednesday to the way prescription drug labels explain what is known about the risks of a medication's use by pregnant and breast-feeding women.
In many cases there remains little information about how medicines may affect a fetus or breast-fed infant. Doctors have complained data that was available did not always appear on drug labels, or was presented in a confusing format.
The new plan would eliminate categories now used on prescribing instructions for doctors to indicate the risk to a fetus, the Food and Drug Administration said.
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.
Future drug labels would carry three summaries that included information about risks to the fetus, the effects of the disease on mother and baby and supporting data.
A lactation section would detail what is known about a drug's potential effects on a breast-fed infant.
About six million pregnancies occur in the United States each year and pregnant women take an average of three to five prescription drugs during pregnancy, the FDA said.
The medicines may treat complications of pregnancy, 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 using a medication during pregnancy.
The FDA said it recognized shortcomings of pregnancy and breast-feeding information in drug labels in the 1990s and had been considering improvements since then.
The agency heard concerns the letter system "led to an inaccurate and overly simplified view" of risks, Sandra Kweder, deputy director of the FDA's Office of New Drugs, told reporters during a conference call.
The new format was 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.
Diana Zuckerman, president of the National Research Center for Women & Families, said the consumer group supported eliminating the letter categories. But the drug labels "can't be very good as long as there is so little research on which medications are safe for pregnancy and nursing," she added.
The March of Dimes, a group that works to prevent birth defects, welcomed the plan.
"It makes it clearer for everyone, including the lay people who might want to consult it," said Dr. Michael Katz, a senior vice president at the March of Dimes.
More information has been developed in recent years about drugs' effects on a fetus and 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.
(Reporting by Lisa Richwine; Editing by Andre Grenon)
