Black Box Warning

Last updated on: 02.03.2025

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DefinitionThis section has been translated automatically.

A black box warning (also known as a boxed warning) is the highest warning level issued by the US Food and Drug Administration ( FDA ) for prescription drugs. This warning is highlighted in a black box on the drug's packaging or package insert to indicate serious or potentially life-threatening side effects.

Field of application/useThis section has been translated automatically.

Features of a black box warning:

Highest FDA warning level:

  • Issued only when there are significant risks that may be life-threatening.

Marked by a black box:

  • The warning is visually highlighted to make the meaning clear to physicians and patients.

Target group:

  • Doctors and pharmacists should be informed of serious risks to ensure safe use.
  • Patients can also be warned, especially if the risk is not covered by normal safety instructions.

Reasons for a black box warning:

  • The drug may have fatal or irreversible side effects.
  • There is a high risk of serious drug interactions.
  • The medication poses risks if used incorrectly (e.g. in the event of an overdose).

Examples of drugs with black box warnings:

  • Opioids (e.g. oxycodone, fentanyl): Risk of respiratory depression and dependence.
  • Antidepressants (e.g. SSRis): Increased risk of suicide in adolescents and young adults.
  • Isotretinoin (for acne): Severe birth defects in pregnant women (Strauss JS et al. 1988)
  • Topical calcineurin inhibitors (2006): Risk of malignant degeneration (Po-Chien Wu et al. 2021)

Why are black box warnings important?

  • They help physicians to make an informed decision about the benefits and risks of a drug.
  • Patients can be better informed about potential dangers.
  • They help to avoid serious side effects by specifically pointing out risks.

Despite a black box warning, these drugs can be prescribed if their benefits outweigh the risks. However, doctors must be particularly careful and monitor patients carefully.

LiteratureThis section has been translated automatically.

  1. Po-Chien Wu et al (2021) Topical calcineurin inhibitors and the risk of lymphoma: a systematic review and meta-analysis. JDDG 19:1265-1270
  2. Strauss JS et al (1988) Isotretinoin and teratogenicity. J Am Acad Dermatol 19:353-4.

Last updated on: 02.03.2025