News
Medications and Pregnancy
About six million pregnancies occur in the United States each year. Drug labels in U.S. will be changed because in many cases there remains little information about how medicines may affect a fetus. A new format of labels will be practical and useful to clinicians and patients who have to make very difficult decisions.
U.S. officers explain that till now in most medications very little is known about the risks of a medication's use by pregnant and breast-feeding women and about the way they can influent on breast-fed infant. Some doctors complained that even if it appeared that this data was available, it did not always appear on drug labels, or was presented in a confusing format.
The Food and Drug Administration developed a brand new way for labelling the medications. Thus, a category "A" drug means that it doesn't lead to birth defects, while "X" means that drug should not be used during pregnancy. Other letters denote different levels potential harm, or a lack of data. Three compulsory summaries of the future labels will include information about risks to the fetus, the effects of the disease on mother and baby and supporting data. Also there will be a special breast-feeding section, which would detail what is known about a medicine's potential effects on a breast-fed baby.
The Pharmaceutical Research and Manufacturers of America, an industry group, is reviewing the proposal, spokesman Ken Johnson said.
