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The FDA is pushing for changes in physician labeling for prescription drugs that would more clearly state what research shows about a drug's risks to fetuses and breast-feeding infants. Currently, prescription drugs are coded A,B,C,D, and X, which is intended to rank their relative safety during pregnancy. In practice, however, the system may convey misleading, incomplete, or ambiguous information.
To provide better information to health care professionals, proposed labels would remove the letter codes and replace them with the following three sections of information:
* fetal risk summary-a description of what's known about a drug's effects on a fetus and the basis for this knowledge; for example, whether research is based on human or animal data.
* clinical considerations-the effects of a drug if a woman takes it before knowing that she's pregnant, including information about dosing and possible complications.
* data-more details on available research, including data used to develop the fetal risk summary.
For more information, go to http://www.fda.gov/cder/regulatory/pregnancy_labeling/http://default.htm.
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