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Volume 354:2409-2411 June 8, 2006 Number 23
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Highlights and a Hidden Hazard — The FDA's New Labeling Regulations
Jerry Avorn, M.D., and William Shrank, M.D., M.S.H.S.

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The Food and Drug Administration (FDA) is trying to make the official descriptions of prescription drugs — which are notoriously user-hostile — more helpful. The agency has acknowledged the linguistic toxicity of these documents, known as package inserts or labeling. These are the lengthy listings of drug indications, effects, and associated risks that are routinely included with medications when they are shipped to pharmacies — and just as routinely discarded by pharmacists before any drug is dispensed to patients. Physicians are more likely to see the labeling in tiny print in the voluminous Physicians' Desk Reference (PDR), one of the . . . [Full Text of this Article]


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Dr. Avorn is a professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital — both in Boston. Dr. Shrank is an instructor at Harvard Medical School and in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital.


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