black box warning


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A cautionary label for all therapeutic agents and/or products—and relevant literature—that the FDA regards as being hazardous to health if incorrectly administered

black box warning

A written advisory supplied by a pharmaceutical company to health care professionals whenever a medication causes any serious side effect(s). Under U.S. federal regulations, this advisory is mandatory and must be highlighted by “a prominently displayed box.”
References in periodicals archive ?
Antipsychotics already carry black box warnings about increased mortality in this population.
"Although this was a relatively small study, the fact that almost one in four prescriptions for metformin were being prescribed against the black box warning may be significant," said Dr.
He acknowledged that after the black box warning was added to the labels of antidepressants, there was evidence of a drop in prescriptions.
A 2007 study from the Mayo Clinic reported no documented cases of torsades de pointes among the 16,791 patients exposed to droperidol over the 3-year period preceding the black box warning. The authors concluded that the FDA warning for low-dose droperidol was excessive and unnecessary (Anesthesiology 2007,107:531-6).
The product includes a so-called black box warning with information on the potential risk of hypersensitivity reactions.
The vote on the black box warning followed discussion of the trade-offs involved in elevating the risk information to that level.
The analyst also points out that the label includes a Black Box warning for thrombocytopenia and glomerulonephritis requiring every 2-week monitoring, and will be marketed by Ionis subsidiary Akcea (AKCA) with a Risk Evaluation and Mitigation Strategy.
Depot medroxyprogesterone acetate and bone mineral density in adolescent--the black box warning: A position paper of the Society for Adolescent Medicine.
Antipsychotics once were widely prescribed as an off-label treatment for dementia, but in 2005, the Food and Drug Administration issued a black box warning that the use of atypical antipsychotics in the treatment of behavioral disorders in elderly patients with dementia was associated with increased mortality.
At a joint meeting of the Food and Drug Administration's Peripheral and Central Nervous System Drugs and Psychopharmacologic Drugs advisory committees, the panel members agreed with the evidence indicating an increased suicidality risk and that this information needed to be communicated to physicians and patients, but they voted 14-4 with 3 abstentions against the FDA's proposal to include it in a black box warning in the labels of all antiepileptic drugs (AEDs).
For a physician, a black box warning is "a big deal" and "comes with a very negative connotation" that could influence a physician to question whether a patient needs a drug, said the acting panel chair, Dr.