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Rx label changes affect OTC use?

This article was originally published in The Tan Sheet

Executive Summary

FDA's proposal to update the format of the pregnancy and lactation sections of drug labeling may encourage women to use "safe and effective products," including Rx drugs that "they might otherwise avoid" because of safety concerns, the agency says. The rule published in the May 29 Federal Register would require labels to include "up-to-date information on the risks and benefits of prescription drugs" on pregnant women, their fetuses and lactation. FDA cites studies that found pregnant women often take OTC drugs and dietary supplements instead of prescription products because they perceive those products are safer, even though safety information on OTC products and supplements "is as limited, if available at all, as that for prescription drugs"...

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