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 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.
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.
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.
The black-box warning on antidepressant product labeling, however, states that "antidepressants increase the risk of suicidal thinking and behavior .
Roche sent a letter to doctors describing the new pregnancy warnings, which were added to an existing black-box warning on the drug.
The FDA issued the black-box warning after a safety review indicated an increased risk of suicide among pediatric antidepressant users.
8 percent after the FDA issued black-box warnings in October 2004, according to a study being presented today by i3 Research at the National Institute of Mental Health's New Clinical Drug Evaluation Unit (NCDEU) annual meeting in Boca Raton.
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.
In the case of salmeterol--which already has a black-box warning on its label about the small but significant increase in asthma-related deaths in treated patients in a large postmarketing trial--the panel recommended that the warning against the use of monotherapy with long-acting [[beta].
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
Black-box warnings on all the TNF antagonists advise skin testing all patients prior to starting therapy.