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