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 findings run counter to the Food and Drug Administration's black-box warning that patients should reduce use of LABAs such as salmeterol or formoterol after achieving asthma control.
"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.