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 ?
Does the FDA's black-box warning on estrogen contribute to noncompliance--or worse, to clinicians being unwilling to prescribe estrogen treatments--leaving many women to suffer untreated menopause symptoms?
Does the Food and Drug Administration's black-box warning on estrogen contribute to noncompliance--or worse, to clinicians being unwilling to prescribe estrogen treatments --leaving many women to suffer untreated menopause symptoms?
The order requires that sunlamp products carry a visible black-box warning that explicitly states that the sunlamp product should not be used on persons under the age of 18 years.
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.
AN APPEAL TO THE FDA: REMOVE THE BLACK-BOX WARNING FOR DEPOT MEDROXYPROGESTERONE ACETATE"
Lexington MA) breathed a sigh of relief after the FDA did not ask the drugmaker to carry a black-box warning on its key drug Feraheme, sending the company's shares up 16% for the week.
COMMENT Given the FDA's black-box warning, it is imperative that we counsel and document concerning the risk of suicide when initiating therapy for depression.
Despite the criticisms, the FDA expanded the black-box warning in May 2007 to all patients under 24 years old.
In the WHI, estrogen was administered to 8,506 women over age 50, including 880 smokers, despite the black-box warning that "cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use.
The petition asked the agency to require manufacturers to add a black-box warning, send a "Dear Doctor" letter to physicians about the risk, and distribute an FDA-approved medication guide to be dispensed to patients when prescriptions for the antibiotics are filled.
A black-box warning is the strongest type of advisory under the FDA system.
Women over 75 were most likely to be prescribed drugs in violation of a black-box warning.