Drug Labeling with Pregnancy in Mind

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The Checkup
Copyright 2008
Monday, June 2, 2008; 7:41 AM

When you're pregnant, or thinking about getting pregnant, there are so many things to consider: Are you ready emotionally? Financially? Physically? Once you've addressed those issues, many other important questions remain -- including this one: Are your prescription drugs safe for you to take while you're pregnant? The U.S. Food and Drug Administration has been working for more than a decade to make that question easier for women and their doctors to answer. Late last week the agency took another step in that process, proposing new drug-labeling guidelines that aim to more clearly and thoroughly spell out a drug's potential risks and benefits to a pregnant or nursing mother and her baby. The new system would require drug labels to provide three categories of information: * a "Fetal Risk Summary," telling what's known about a drug's effect on a fetus; * "Clinical Considerations," listing what's known about the drug's effects



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