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 ?
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.
But she defends the black-box warnings as a benefit to doctors and patients alike.
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.
Alexander Fariborzian, MD, medical director of Meridian Behavioral Healthcare in Gainesville, Florida, which serves 11 counties in North Florida, says the organization began issuing "advisories" to parents after the black-box warning went into effect.
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 Food and Drug Administration (FDA) should remove the black-box warning regarding skeletal health that the agency inserted into labeling for the injectable contraceptive depot medroxy-progesterone acetate (DMPA; Depo-Provera) in 2004.
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.
The FDA issued the black-box warning after a safety review indicated an increased risk of suicide among pediatric antidepressant users.
The firm has been acknowledged as playing a significant role in bringing about black-box warnings on the labels of more than 30 antidepressants concerning the increased risk of suicidality in children, adolescents and young adults