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FDA Hopes New Inserts Will Clear Confusion Over Prescription Drugs

Posted January 20, 2006

— Every prescription drug comes with a paper insert of information. It is required information that includes everything from clinical trial results to the drug's chemistry. Some argue that there is so much information that it is hard to find essential information such as dosage and side effects.

The government believes all that confusion is partly to blame for thousands of adverse events that occur with medications each year in the United States.

The Food and Drug Administration hopes new easy-to-read and easy-to-understand labels can cut that number down.

"The FDA is delivering on what we need -- information that is accessible, understood, timely and memorable," said U.S. Surgeon General Dr. Richard Carmona.

Among the additions, prescribing instructions, benefits and risks will be highlighted and easy to find. A new table of contents will be added, making it easier to locate safety information.

"This initiative clearly makes things a lot easier for the practitioner to get that information to the patient," Carmona said.

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.

The new drug inserts will also include information about drug interaction and a toll-free phone number to report suspected side effects to the FDA.


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