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U.S. Department of Health and Human Services

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Why do some drug labels get changed so often ?

Drug labels are changed frequently so that they contain the most up-to-date information about the drug. After an approved drug is marketed and used by many more people than those originally tested, new information often emerges about the product, for example

  • new side effects
  • new ways of dosing
  • new uses for the drug

This new information is added by the manufacturer to the drug’s label so consumers and health care professionals have all the information necessary for safe and effective use of the drug.

All changes to a drug’s label must be approved by FDA. The manufacturer sends proposed changes to FDA that FDA reviews, revises if necessary, and approves. After approval, the manufacturer prints a new label.

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