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what is a black box warning?

In the United States, a black box warning (also sometimes called a black label warning or boxed warning[1]) is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. It is so named for the black border that usually surrounds the text of the warning.
A black box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. The U.S. Food and Drug Administration (FDA) can require a pharmaceutical company to place a black box warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires.
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July 3, 2007 -- The asthma drug Xolair has a new "black box" warning about severe, potentially life-threatening allergic reaction (anaphylaxis).
In February, the FDA requested Xolair's maker, Genentech, to put the boxed warning on Xolair. Now, those warnings have been added to Xolair's packaging.
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The Food and Drug Administration (FDA) announced today that a "black box" warning, highlighting prolonged use may result in the loss of bone density, will be added to the labeling of Depo-Provera Contraceptive Injection, an established injectable drug approved for use in women to prevent pregnancy.
Although Depo-Provera Contraceptive Injection has been used for decades for birth control throughout the world and remains a safe and effective contraceptive, FDA and Pfizer, the drug's manufacturer, are taking this action to ensure that physicians and patients have access to this important information.
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