Chicago, The Food and Drug Administration said it would streamline and improve the prescription drug information commonly called the ``package insert,'' which experts said may help reduce medical errors and harmful side effects.

The changes, the first major revamp of the inserts in more than 25 years, are designed to replace clutter and complexity with clarity and simplicity so doctors can obtain the best information on a product before prescribing it, officials said.

That will translate into ``better health outcomes for patients and more efficient delivery of health care,'' said Health and Human Services Secretary Mike Leavitt.
Each year, about 300,000 preventable adverse events occur in U.S. hospitals, many caused by confusing medical information. Research has shown that prioritizing warning information can reduce such events.

``Americans are overwhelmed with the complexity of health information. We have hit a point of information overload and the public-health message is being diluted,'' said U.S. Surgeon General Richard Carmona. ``This problem is compounded by prescription medication information that reads more like legal disclaimers than useful or actionable health information.''

The new format requires that information for new and recently approved prescription products meet specific graphical requirements, including the reorganization of critical information so physicians can find it quickly. The changes will be phased in gradually for newer drugs already on the market.

Some of the most significant changes include a ``highlights'' section listing the most important information about benefits and risks, a table of contents for easy reference to detailed safety and efficacy information, and the date of initial product approval, making it easier to determine how long it has been on the market.

A toll-free number and Internet contact will be included to encourage more widespread reporting of suspected side effects.

Moss said the new rules may help doctors avoid making prescription mistakes, especially when prescribing drugs that are new or that they seldom use.

Some experts said the FDA revisions, though welcome, don't go far enough.

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