Black box warning
A boxed warning , sometimes black label warning in English: boxed warning (framed warning), is one in the USA valid way on the package inserts of prescription drugs from serious side effects to warn. The name comes from the black frame that surrounds the text of the warning.
Drug manufacturers are requested by the US Food and Drug Administration (FDA) to include a black box warning when medical studies indicate that taking a drug is associated with a risk of serious or even life-threatening side effects . Such a warning can be required for package inserts or for literature on the respective drug. The black box warning is the strongest possible form of a warning issued by the US-FDA.
Examples:
- Warning of fatal bleeding risks with the anticoagulant warfarin , was used as a black box warning on October 9, 2006
- Warning of the risk of accelerated tumor growth in cancer patients taking erythropoietin , was used on November 8, 2007
- Warning of the risk of tendonitis and rupture under the antibiotic group of fluoroquinolones , has existed as a black box warning since July 8, 2008
Individual evidence
- ↑ Information from the US FDA on the content and format of the Black Box warnings (Guidance for Industry Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products) . Retrieved November 15, 2015.
- ^ Black Box for Warfarin . Retrieved August 15, 2007.
- ↑ Erythropoietins: Dangerously thick blood . Retrieved July 9, 2008.
- ↑ FDA orders 'black box' label on some antibiotics . Retrieved July 8, 2008.
Web links
- Drug Safety-related Labeling Changes (SrLC) , FDA database of labeling changes related to drug safety ( boxed warning , contraindications, side effects, interactions, etc.)