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.
He's concerned that many physicians may be interpreting the FDA's black box warning as an indication that patients should discontinue DMPA after 2 years.
Other committee members cited the potential for decreased use as an attractive feature of the black box warning.
Black box warnings on antipsychotics led to a decrease in their use to treat patients with dementia, without a commensurate increase in use of antianxiety or other psychotropic agents but with a rise in the use of anticonvulsant therapies, some of which appear to be riskier than the antipsychotics in older patients.
During the open public hearing portion of the meeting, representatives of the American Epilepsy Society, the American Academy of Neurology, and the Epilepsy Society expressed concerns that a black box warning about suicidality in AED labels could affect patient compliance.
But the APA is concerned about continuing unintended consequences of the black box warning and is exploring other ways to inform physicians about the risks of antidepressant therapy, Dr.
The black box warning notes that women who use Depo-Provera may experience a significant decrease in BMD that might not be completely reversible after discontinuing use.
The warning follows closely a petition in January by a Washington-based advocacy group, Public Citizen, which is seeking a black box warning, claiming FDA data show the toxins often spread beyond the therapeutic area.
MAUI, HAWAII -- A thorough familiarity with the age-specific indications for topical steroids in children with atopic dermatitis has become essential in the aftermath of the Food and Drug Administration's black box warning on topical calcineurin inhibitors, speakers said at the annual Hawaii Dermatology seminar sponsored by Skin Disease Education Foundation.
MADRID -- Prescriptions for atypical antipsychotics have not decreased significantly among elderly patients with dementia, despite the black box warning of an increased risk of death associated with the drugs, Henry Riordan, Ph.
The existing black box warning on estrogen/progestin products contains WHI information about increased cardiovascular risks associated with the agents.