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In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize its ...
The US Food and Drug Administration has placed its most serious warning — a so-called black-box warning — on a drug used to relieve menopausal hot flashes.
Cyclophosphamide (CP), also known as cytophosphane among other names, [3] is a medication used as chemotherapy and to suppress the immune system. [4] As chemotherapy it is used to treat lymphoma , multiple myeloma , leukemia , ovarian cancer , breast cancer , small cell lung cancer , neuroblastoma , and sarcoma . [ 4 ]
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When in December 2023, the FDA approved Bluebird Bio's Lyfgenia (lovotibeglogene autotemcel (lovo-cel)) cell-based gene therapy for sickle cell disease, a black box warning was included in the ...
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There is a black box warning on WinRho SDF due to the risk of potentially fatal intravascular hemolysis when used in the treatment of ITP. [21] Life-threatening anemia, kidney failure, and disseminated intravascular coagulation (DIC) have occurred in people treated with WinRho SDF for ITP. [citation needed]
(Reuters) -The U.S. health regulator on Monday asked a host of drugmakers, including Gilead Sciences, Johnson & Johnson and Novartis, to add a serious warning on the label of their cancer ...