FDA unveils new inserts for prescriptions

WASHINGTON – Package inserts that accompany every prescription drug are getting a major makeover that will provide doctors and patients with the clear and concise information they need while cutting down on the small-print warnings that only lawyers seem to understand.

Confusing medical information is behind many of the estimated 300,000 preventable cases of death or injury that occur each year in the nation’s hospitals, the Food and Drug Administration said Wednesday in publishing new rules on prescription drug labeling.

“We are making the prescribing information much more targeted and useful for physicians,” said Dr. Janet Woodcock, the FDA’s deputy commissioner for operations. “The prescribing information over the years, as we learned more and more about medicines, has become very congested and complex. We’ve heard from physicians it’s hard for them to find the information they need.”

Patients should benefit as well.

Features that prescription drug labels will begin bearing include:

* The date the drug received initial U.S. approval.

* Recent major changes to information about the drug.

* A toll-free phone number for patients or doctors to report suspected side effects to the FDA.

* Drug interaction information gathered in one section.