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.
|Increased mortality in older patients with dementia-related psychosis.|
|Increased risk of tendon rupture/damage. This risk is heightened in elderly patients, and in those who take corticosteroids.|
|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|
|Risk of addiction, misuse, abuse. Life-threatening respiratory depression.|
|Long-acting beta-2 agonists||Formoterol|
|Increased risk of asthma-related death. Should be used in combination with an inhaled corticosteroid such as fluticasone or budesonide.|
|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!