What is a Black Box Warning?

A black box warning is a notice on the packaging of a prescription drug that warns patients and prescribers that the drug has potentially dangerous side effects. This alert system is primarily used by the Food and Drug Administration (FDA), a US regulatory body that monitors the safety of drugs manufactured and sold in the United States. Other national regulatory agencies may use different systems to indicate that drugs are potentially dangerous.

When a drug receives a black box warning, it means that studies on the drug have suggested that it may have harmful or even fatal side effects. These warnings are often postulated as a result of information about a substance that has been discovered during routine use. When health professionals begin reporting dangerous side effects for a prescription drug, the FDA may hold a review to determine whether the drug requires a label warning.

“Black box” in this term refers to the bold black frame drawn around the warning. This limit is designed to draw attention to the warning, and to offset it from other information that may be present in pharmaceutical packaging. Thanks to widespread public awareness of the consequences of a black box warning, a black box on the drug packaging acts as a warning that the drug is dangerous even before people read the text.

Black box warnings usually have to be included on the packaging of the drug, and in the printed inserts used to provide information about the drug to patients and prescribers. They are designed to alert patients to the potentially dangerous of the drug, and they also alert pharmacists and other medical professionals. Patients who receive a drug with this type of alert may want to discuss it and its implications with health care professionals, as people should not take medication with potentially fatal side effects without knowing what these side effects are and how to recognize them.

Some notable examples are warnings about antidepressants that indicate that these drugs can lead to suicidal thoughts in teens and children, and the warning of the anticoagulant drug warfarin about the risk of bleeding to death while on medication. As a general rule, drugs with very serious side effects are left on the market because their benefits are seen as more valuable than their potential dangers, although a black box drug will sometimes be removed from the market after evaluation by the FDA.

  • Black box warnings alert patients and pharmacists to the dangers of a drug.
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