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 – serious or life-threatening adverse effects.
When a black-box warning is issued, it informs healthcare providers and prescribers of serious adverse effects of specific drugs and enhances their clinical judgment. For example: when atypical antipsychotics were assigned a black box warning for use in patients with dementia (as it increases the risk of death) – prescription use of antipsychotics for this population declined thereafter.
The same is true for many other medicines, too. For instance, when the antidiabetic drug – rosiglitazone – was issued a black box warning, use of that medicine declined by almost three-quarters. Prescribers seek alternative medicine choices to reduce any potential risk to the affected population.
Here, we have put together a list of black-box warnings that both prescribers and pharmacists must know. Bear in mind that this is not intended to be a complete list of black box warnings.
| Drug/Drug Class | Examples | Warning |
|---|---|---|
| Antipsychotics | Quetiapine Haloperidol Olanzapine Risperidone | Increased mortality in older patients with dementia-related psychosis. |
| Atypical antipsychotic | Clozapine | Agranulocytosis |
| 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 with most other antidepressants, such as SNRIs. |
| Antiarrhythmic | Amiodarone | Increased risk of pulmonary toxicity, hepatotoxicity, and heart block. |
| Antimalarials | Mefloquine | Increased risk of neuropsychiatric effects such as anxiety, depression, seizures, hallucinations, and loss of balance. |
| Monoclonal antibody | 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. |
| Fatty acids | Valproic acid | Hepatotoxicity Pancreatitis |
| Opioids | Oxycodone Morphine Hydrocodone Fentanyl | Risk of addiction, 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 such as fluticasone or budesonide. |
| Sodium blockers | Carbamazepine Lamotrigine | Life-threatening skin reactions such as Stevens-Johnson syndrome, DRESS syndrome, and toxic epidermal necrolysis (TEN). |
| Direct thrombin inhibitor | Dabigatran | Blood clot formation that can cause permanent paralysis if the drug is injected into the patient’s spinal/epidural area; or have a spinal puncture. |
| Xanthine oxidase inhibitor | Febuxostat | Increased risk of serious cardiovascular events. |
| Tyrosine kinase inhibitors | Nilotinib | Increased risk of QT prolongation. |
| Thiazolidinediones | Pioglitazone | Increased risk of heart failure. |
| Tetracyclines | Tigecycline | Increased risk of death when given IV for serious infections such as ventilator-associated pneumonia and complicated intra-abdominal infections. |
| IBS medicine | Linaclotide | Increased risk of serious dehydration in children under 6-years. Linaclotide should be avoided in 6-18 years, too. |
| Tyrosine kinase inhibitor | Cabozantinib | Holes forming in the stomach (GI perforation), as well as the risk of GI fistulas. |
That’s it for now! Check back to our pharmacy blog soon for even more exclusive content on the must-know facts about drugs and medicines!
