Black box warnings get their name from how they display on drug packaging inserts. The warnings display inside an eye-catching box with a thick black outline. They’re typically in bold font to make the warnings even more noticeable.
The medications that receive boxed warnings may be subject to constant review, and the Food and Drug Administration (FDA) can update, add, or remove them at any time.
About black box warnings
The FDA regulates all prescription and nonprescription medications in the United States. This includes product labeling and the information given on mediation boxes.
Some FDA advice alerts doctors and those receiving medication to high risk drugs that have the potential for dependence, serious side effects, and reactions, or to alert to other important safety measures. Currently, over 400 drugs have boxed warnings.
The FDA will often give boxed warnings when the risks outweigh the benefits, and they deem the risk serious enough that a doctor or healthcare professional should make appropriate considerations before prescribing the drug.
Additionally, prescribing and dispensing healthcare professionals may require additional training on when not to give the medication or how to recognize when a potential drug interaction may occur.
Reporting reactions to the FDA
The FDA gathers important safety information through studies and clinical trial data, but one of the other ways they make safety decisions is by people reporting their experiences to MedWatch.
This voluntary reporting program allows you to report adverse reactions and product quality concerns.
You can fill out a report online or print the forms from the website.
Which drugs carry a black box warning?
Typically, boxed warnings will apply to a group of drugs rather than one specific drug. This is because the risks will apply to how the drugs work, and there is often more than one drug with the same function.
Boxed warnings are always in a place that will garner the most attention, with the FDA dictating placement.
Below, we will look at some drugs with back box warnings.
Typical antipsychotics
The FDA gives both atypical and typical antipsychotic medications black box warnings. Typical antipsychotics work on the brain’s dopamine receptors and often have fewer or less severe side effects than atypical antipsychotics. These drugs and their warnings include:
- Haloperidol (Haldol): This drug has a boxed warning to advise of an increased risk of death in older adults with dementia-related psychosis.
- Thiothixene (Navane): The boxed warning for this drug advises of an increased risk of death in older adults with dementia-related psychosis.
- Perphenazine (Trilafon): This drug’s boxed warning advises of an increased risk of death in older adults with dementia-related psychosis.
- Loxapine (Adasuve): The boxed warning for this drug warns of an increased risk of death in older adults with dementia-related psychosis.
Atypical antipsychotics
These drugs work on the brain’s dopamine and serotonin receptors. They can also have antidepressant capabilities due to the effects on serotonin. Some of these include:
- Aripiprazole (Abilify): This drug’s boxed warning advises an increased risk of death in older adults with dementia-related psychosis and suicidal thoughts and behaviors with antidepressant drugs.
- Ziprasidone (Geodon): The boxed warning on this drug advises of an increased risk of death in older adults with dementia-related psychosis.
- Risperidone (Risperdal): This drug’s boxed warning advises of an increased risk of death in older adults with dementia-related psychosis.
- Quetiapine (Seroquel): The boxed warning on this drug includes advice on an increased risk of death in older adults with dementia-related psychosis and suicidal thoughts and behaviors in children, adolescents, and young adults.
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