Beware the fine print

To overhaul the drug warnings to physicians usually found in fine print on drug packages or package inserts, the Food and Drug Administration proposed new regulations for new prescription drug packaging.

According to the Food and Drug Administration (FDA), the proposed warning format will allow doctors to find the most important information about the product quickly, thereby reducing medical errors that may be responsible for as many as 98ꯠ deaths annually and enhancing the safety and effectiveness of treatment. An FDA survey indicated that doctors found drug product labels to be "lengthy, complex and hard to use." Apparently, many give little or no attention to the warnings.

    Under the proposal, the label would contain the following information in order:
  • A "highlights" section that begins with the key warning
  • A notice of any additional warnings that have been added in the preceding year
  • Proper dose
  • Important side effects and an FDA phone number (in bold print) to report suspected problems
  • An index of each topic detailed in the warnings section of the label
  • A "patient counseling" section containing everything consumers need to know before taking the medication

The new labeling format will apply to what FDA calls "relatively new prescription drug products" because the warnings are most critical for newer and less familiar drugs and because the revisions "represent considerable effort" to implement.

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