What are black box warnings?

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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Fluoroquinolones

Fluoroquinolones are antibiotics that typically treat bacterial infections. Some of these drugs with boxed warnings include:

• Moxifloxacin (Avelox): The boxed warning advises of an increased risk of:

• tendinitis
• tendon rupture
• peripheral neuropathy
• central nervous system (CNS) effects
• worsening of myasthenia gravis

• Ciprofloxacin (Cipro): This drug’s boxed warning advises of:

• tendinitis
• tendon rupture
• peripheral neuropathy
• CNS effects
• worsening of myasthenia gravis

Selective serotonin reuptake inhibitors (SSRIs)

SSRIs are antidepressants that work by increasing serotonin levels. Some of these drugs include:

• Sertraline (Zoloft): The boxed warning for this medication advises of the increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults.
• Paroxetine (Paxil): This drug’s boxed warning advises of a possible increase in suicidal thoughts and behaviors in children and young adults.
• Fluoxetine (Prozac): The boxed warning for this medication advises of an increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults.
• Escitalopram (Lexapro): The boxed warning for this medication advises of the increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults who are taking antidepressants for major depressive disorder (MDD). The FDA does not approve this medication for those under 12 years old.

Opioids

The following opioids are prescription-only pain relievers for moderate to severe pain. All opioids are controlled substances due to the risk of misuse.

• Oxycodone (Oxycontin): The boxed warning for this drug advises the risk of addiction, overdose, and misuse. It is a schedule II controlled substance.
• Morphine (Ms Contin): This drug’s boxed label advises of the risk of addiction, overdose, and misuse, with the added risk of associated drug interactions from benzodiazepines and other CNS depressants.
• Hydrocodone (Zohydro): The boxed label for this medication advises of the risk of addiction, overdose, and misuse, alongside life threatening respiratory depression. It also advises of the risks from associated drug interactions from benzodiazepines and other CNS depressants. Hydrocodone also interacts with alcohol.
• Fentanyl (Duragesic, Subsys): This medication’s boxed label advises of the risk of addiction, overdose, and misuse, alongside life threatening respiratory depression. It also advises of the risks from associated drug interactions from benzodiazepines and other CNS depressants. Additionally, as this medication releases into the body via a patch, the label warns that absorption will increase with external heat.

Summary

Boxed warnings, also called black box warnings, are notifications displayed on prescription medication packaging.

The FDA places these warnings following studies and the reporting of adverse side effects. The warnings alert healthcare professionals and anyone taking the medication to the significant and serious health risks associated with a particular drug.

Warnings may include the risk of addiction, misuse, suicidal thoughts, and sometimes death. Your doctor or prescriber should consider FDA advice before they decide on your treatment to ensure the safest plan is in place.

You may not always receive the package insert from your pharmacist or dispensary, but they typically provide separate written guidance if the drug has a warning.

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