black-box warning


Also found in: Dictionary, Wikipedia.

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 researchers undertook the meta-analysis because of the ongoing controversy over whether to withdraw or continue LABAs once asthma is adequately controlled, as the FDA recommends in a black-box warning for the drugs.
In December 2006, Columbia University psychiatry professor John Mann testified at a public FDA hearing that antidepressant prescriptions to young people declined 22% after the black-box warnings were imposed.
Why did GEC/WHI physicians give estrogen to smokers despite the black-box warning? Why did the study design of WHI include smokers?
"Given the importance of the issue and given the continuing reports of injuries that could be prevented if physicians and patients were better advised," a more pronounced black-box warning is needed, Kirkpatrick said.
"Psychiatrists and nurse practitioners at our organization believe that the black-box warning and the additional focus with parents on risk potential have decreased parental acceptance of these medications," says Karen Rhea, MD, a child and adolescent psychiatrist and vice-president for medical services for Centerstone, a large community mental health provider organization in Tennessee.
asked the manufacturer and its generic counterparts made by Par and Teva to add heart valve damage to the warnings section of the agent's labeling, which was upgraded to a black-box warning in 2006.
As with all members of this drug class (nucleoside reverse transcriptase inhibitors), the prescribing information carries a black-box warning about risk of lactic acidosis and liver toxicity.
The FDA black-box warning states that LABAs should be discontinued as soon as asthma control is achieved, but this meta-analysis shows that such withdrawal "results in loss of stability in multiple domains that capture different aspects of asthma control," they said.
Elderly nursing home residents who receive antipsychotic drugs almost always receive them for off-label conditions, including conditions flagged in a black-box warning on the medications' labeling, according to a report from the Department of Health and Human Services Office of Inspector General.
Roche sent a letter to doctors describing the new pregnancy warnings, which were added to an existing black-box warning on the drug.
In addition, the agency has directed manufacturers to add a so-called black-box warning to the drugs' labeling, describing antidepressants' risks and emphasizing the need for strict monitoring of patients taking the drugs.