black-box warning

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black-box warning

n.
A written warning regarding the serious adverse effects of a prescription drug, required by the Food and Drug Administration on packaging and usually contained within a black rectangular border.
References in periodicals archive ?
The FDA should act swiftly on the clear scientific evidence and add black box warnings to both classes of medication.
Although the FDA issued its black box warning last year," said Scott Nabers, of Blizzard, McCarthy & Nabers, which represents dozens of patients disabled by Reglan, "many doctors and patients are still not aware of the significant risks associated with its use.
The decline accelerated after the black box warning.
GlaxoSmithKline's smoking cessation drug, Zyban, will also put a black box warning on its label, based on reports of unusual changes in behavior, becoming depressed, or having suicidal thoughts while taking the drug.
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.
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.
A black box warning detailing this use and highlighting anaphylactic-like reactions associated with Eloxatin is included in the labeling.
The medication carries a black box warning that Sirturo can affect the heart's electrical activity, which could lead to an abnormal and potentially fatal heart rhythm.
A black box warning says that it may extend beyond the area of injection, resulting in temporary paralysis that could affect swallowing and breathing.
The first strategy when counseling a parent about a black box warning is to be prepared--access the studies and know the evidence.
This was also a concern when the FDA added the suicidality black box warning to antidepressants, and for this reason the warning was added to the older tricyclic antidepressants because of concerns that the warning would drive physicians back to prescribing these older drugs.