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FDA Orders Overhaul of Drug Labeling

FDA Orders Overhaul of Drug Labeling


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Dr. Kim Mulvihill reporting The F-D-A just ordered a major overhaul of prescription drug labeling. It's the first makeover in thirty years.

If you wonder why we need an overhaul, reach into any prescription drug box, and pull out that tiny folded-up piece of paper. You'll find small print and obscure chemical diagrams, that only a chemist or lawyer could love. That's why patients and doctors need a change.

Presently, the inserts are not very user friendly. They're packed with everything from clinical trial results to the drug's chemistry. And sometimes it's hard to figure out how much of a drug to take, when to take it, and even the side effects.

The F-D-A believes these confusing labels are partly to blame for hundreds of thousands of medication errors that occur every year. The agency hopes new easy to read and easy to understand labels can cut down that number.

Janet Woodstock, FDA: You'll be able to look for warnings, precautions, the dosage. You'll be able to look for what the indications are for the drug and who shouldn’t take it right up front:

New Drug Inserts

  • Highlights
  • Table of Contents
  • Drug History
  • Toll-Free Number
  • Website for Adverse Event

Source: FDA Among the additions: a new section called "highlights" that spell out the most important information about the risks and benefits of a drug, a table of contents for easy reference to safety issues, how long the drug has been on the market and a toll-free number and website for suspected adverse events.

The new inserts should start showing up in about four months. Officials hope it will cut down on medical errors and help doctors find what they need faster.

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