Changes in Drug Labels for Pregnant Women
According to a May 2008 report released by the Food and Drug Administration, they are recommending changes to the labels of both prescription and over the counter drugs to make sure that pregnant or nursing women are aware of potential risks of medications. While all the drug labels include fine print warnings of potential interactions, this new proposal will take the risks to pregnant and nursing mothers one step further.
Currently, prescription drugs have a code in fine print that rank their potential risk to pregnant women: Category A means safe; Category X means it's known to harm a developing fetus. Other drugs, which are ranked either B, C or D codes have varying levels of evidence with regard to the safety to the mother and her unborn child.
The FDA is now proposing to change the current Category labeling system with clearly marked sections in the drug's label that describes potential dangers to a developing fetus, as well as information regarding the source of the information, whether potential risks only reflect animal testing, and how the dosage needs to be altered based on whether the patient is either pregnant or nursing.
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