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What are Boxed Warnings?

The strongest form of warning required by the Food and Drug Administration (FDA) for prescription drug labeling. A boxed warning alerts health care providers and consumers to increased risk of serious adverse reactions associated with use of a drug or to restrictions on use of a drug. The boxed warning is presented in a box surrounded by a black border and is placed on the drug label and any package inserts or promotional materials intended for the prescriber or patient.

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The criteria that influence the FDA’s decision on black box warning for drug products include,

  • Identify a drug-associated adverse event prevented through monitoring and intervention,
  • Identify specific patients for whom the treatment is particularly dangerous,
  • Advise that the risks of treatment may outweigh the benefits,
  • Identify a potentially harmful drug interaction or describe critical dosing information,
  • State that the drug administered only by a specially trained health care practitioner or in a special setting, and,
  • Caution that the method of drug administration requires exceptional care.

When is the Black box warning required?

The FDA requires a black box warning for one of the following situations:

  • Firstly, the medication causes serious undesirable effects (such as a fatal, life-threatening or permanently disabling adverse reaction).
  • Secondly, compared with the potential benefit from the drug. Depending on your health condition, you and your physician would need to decide whether the potential benefit of taking the drug is worth the risk.
  • Then, A serious adverse reaction can be prevented, reduced in frequency, or reduced in severity by proper use of the drug.
  • Finally, for example, a medication may be safe to use in adults, but not in children. Or, the drug may be safe to use in adult women who are not pregnant.