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Published on Jan 24, 2006 by Edgar Snyder

Drug Labels Get A Makeover

Drug Labels

After five years of revising the look of drug label inserts, the Food and Drug Administration (FDA) has finally made a decision. Federal regulators believe the drug labels’ new look will reduce injuries and deaths caused by medication mistakes.

Studies have found, an estimated 300,000 people are injured and nearly 100,000 are killed in hospitals each year as a result of medical errors. Prescribing errors account for a large portion of these deaths and injuries. Less than one in ten physicians actually read the drug labels, which provide the most complete data about a drug risks and uses. The FDA says the revised labels will have more specific prescribing information and be more useful to doctors.

The new drug labels will include:

  • A highlights box of the most important information about a drug’s risks and benefits.
  • The date the drug received U.S. approval.
  • Major, recent changes to information about the drug.
  • A toll-free number for reporting side effects to the FDA.
  • Drug interaction information.
  • Key facts doctors should tell patients.

The rule takes effect on June 30 2006, and all new, approved drugs will be required to have the new label design. Drugs approved within the last five years and those under FDA review will be phased in with the new labels.

Source: “FDA to Change Format of Drug Labels for Doctors.” The Associated Press. January 20, 2006.
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