What is a Black Box Warning?

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

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 warning system is primarily used by the Food and Drug Administration (FDA), an American regulatory agency that oversees the safety of pharmaceuticals produced and sold in the United States. Other national regulatory agencies may use different systems to indicate that drugs are potentially dangerous.

The FDA uses a black box warning system to oversee the safety of drugs sold in the United States.
The FDA uses a black box warning system to oversee the safety of drugs sold in the United States.

When a drug receives a black box warning, it means that studies on the drug have suggested that it can have dangerous or even deadly side effects. These warnings are often added retrospectively as the result of information about a drug that has been uncovered in the course of routine usage. When healthcare professionals start reporting dangerous side effects for a prescription drug, the FDA may hold a review to decide whether or not the drug requires a warning on the label.

A pharmacist should clearly explain a black box warning to a customer before giving them the drug.
A pharmacist should clearly explain a black box warning to a customer before giving them the drug.

The “black box” in this term refers to the bold black border that is drawn around the warning. This border 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 implications of a black box warning, a black box on drug packaging serves as an alert that the drug is dangerous even before people read the text.

Antidepressants often contain "black box" warnings.
Antidepressants often contain "black box" warnings.

Black box warnings must typically 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 potential dangerous of the drug, and they also alert pharmacists and other medical professionals. Patients who receive a drug with this type of warning may want to discuss it and its implications with a healthcare provider, as people should not take drugs with potentially deadly side effects without knowing what those side effects are and how to recognize them.

Black box warnings must typically be included on the packaging of the drug.
Black box warnings must typically be included on the packaging of the drug.

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

Mary McMahon
Mary McMahon

Ever since she began contributing to the site several years ago, Mary has embraced the exciting challenge of being a wiseGEEK researcher and writer. Mary has a liberal arts degree from Goddard College and spends her free time reading, cooking, and exploring the great outdoors.

Mary McMahon
Mary McMahon

Ever since she began contributing to the site several years ago, Mary has embraced the exciting challenge of being a wiseGEEK researcher and writer. Mary has a liberal arts degree from Goddard College and spends her free time reading, cooking, and exploring the great outdoors.

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Discussion Comments

Jae Carbon

um. no. the benefits do not outweigh the risks. Please tell me you're not actually spouting that around to people! Any sort of psychoactive drug is unnecessary and detrimental to your health, but especially a black box label psychoactive.

FernValley

@helene55, this is true, although their defense of risks, that te benefits far outweigh them, does still, for the most part, hold true. Although these risks are why it should be advised to avoid these medications unless it is absolutely necessary to take them.

helene55

The unfortunate part of FDA blackbox warnings is that doctors sometimes shrug off these potential dangers, or patients are not informed of other possible things which could add to the threat, such as taking antidepressants with alcohol.

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    • Black box warnings alert patients and pharmacists to the dangers of a drug.
      Black box warnings alert patients and pharmacists to the dangers of a drug.
    • The FDA uses a black box warning system to oversee the safety of drugs sold in the United States.
      The FDA uses a black box warning system to oversee the safety of drugs sold in the United States.
    • A pharmacist should clearly explain a black box warning to a customer before giving them the drug.
      A pharmacist should clearly explain a black box warning to a customer before giving them the drug.
    • Antidepressants often contain "black box" warnings.
      Antidepressants often contain "black box" warnings.
    • Black box warnings must typically be included on the packaging of the drug.
      Black box warnings must typically be included on the packaging of the drug.
    • Prescription drugs may have black box warnings if unexpected side effects are reported.
      Prescription drugs may have black box warnings if unexpected side effects are reported.