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.
On July 8, the Food and Drug Administration (FDA) ordered drug manufacturers to add a "black box warning" (the strongest FDA warning) to the labels of certain antibiotics.
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 agreed 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).
Last February, after receiving reports of liver failure in some patients treated with Ketek, the FDA issued a black box warning - its sternest - and restricted use for patients with pneumonia.
Avandia's black box warning, which is used to treat type 2 diabetes, will have new information about the potential increased risk for heart attacks.
CMS took that action after the Food and Drug Administration added a black box warning in the aftermath of revelations that the drugs can carry potentially fatal side effects when used in cancer patients who are not undergoing chemotherapy.
The committee voted 6-2 in favor of extending the black box warning to include patients under 25 and include the positive adult data.
The choice to take a therapy with a black box warning is a personal issue, and the individual's risk-to-benefit ratio must be carefully considered in consultation with a qualified medical professional.
The new greatly expanded "black box warning" which heads the label warns prescribers, "Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following Mifeprex use" ["Mifeprex" is the U.S.