What are “black box warnings”?

A black box warning – often referred to as simply a “boxed warning” – is the strongest warning issued by the FDA in the United States on drugs that carry specific health risks – often serious or life-threatening adverse effects.

 When a black-box warning is issued, it influences healthcare providers and prescribers. For example – when atypical antipsychotics carried a warning for use in patients with dementia (as it increases the risk of death) – prescription use of antipsychotics for this population declined.

The same is true with other medicines, too. For instance, when the antidiabetic drug – rosiglitazone – was issued with a black box warning, the use of that medicine declined by almost three-quarters. Research shows that prescribers seek alternative medicines to reduce any risk to the affected population.

Below, you can find a list of drugs with a black box warning. Bear in mind that this list is not intended to be complete. However, it does attempt to provide some of the most common and widespread examples in clinical medicine.

List of Black Box Warnings

Here are the top 10 black box warnings that you need to know:

Drug/Drug Class Examples Warning
Antipsychotics Quetiapine
Haloperidol
Olanzapine
Risperidone
Increased mortality in older patients with dementia-related psychosis.
Fluoroquinolones Ciprofloxacin
Moxifloxacin
Levofloxacin
Increased risk of tendon rupture/damage. This risk is heightened in elderly patients, and in those who take corticosteroids.
SSRIs Paroxetine
Fluoxetine
Sertraline
Fluvoxamine
Escitalopram
Increased risk of suicidal ideation, particularly in younger patients. Same risk for other antidepressants, such as SNRIs.
Amiodarone Amiodarone Increased risk of pulmonary toxicity; and hepatotoxicity and heart block.
Antimalarials Mefloquine Increased risk of neuropsychiatric effects such as anxiety, depression, seizures, hallucinations, and loss of balance.
Natalizumab Natalizumab Increased risk of progressive
multilocal leukoencephalopathy (PML).
Progestins Medroxyprogesterone Reduced bone density, particularly in premenopausal women. This effect is reversible once the medicine is discontinued.
Valproic acid   Valproic acid Hepatotoxicity
Pancreatitis
Opioids Oxycodone
Morphine
Hydrocodone
Fentanyl
Risk of addition, misuse, abuse. Life-threatening respiratory depression.  
Long-acting beta-2 agonists Formoterol
Salmeterol
Increased risk of asthma-related death. Should be used in combination with an inhaled corticosteroid (fluticasone, budesonide).
Sodium blockers Carbamazepine
Lamotrigine
Life-threatening skin reactions such as Stevens-Johnson syndrome, DRESS syndrome, and toxic epidermal necrolysis (TEN).

Check back to our pharmacy blog soon for the latest articles on black box warnings, patient safety, and all-things pharmacy!