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    "headline": "FDA Adds Boxed Warning to Iron Injection for Hypophosphatemia Risk",
    "dek": "FDA approves boxed warning for ferric carboxymaltose injection due to symptomatic hypophosphatemia risks.",
    "prose": "The FDA approved a label change for ferric carboxymaltose injection (Injectafer) to add a boxed warning for the risk of symptomatic hypophosphatemia. [^1]\n\nA US district judge granted an FDA request to stay a hearing in a lawsuit filed by Florida and Texas, moving the hearing to December 1. [^2]\n\nResearchers introduced FDARxBench, an expert-curated benchmark for evaluating document-grounded question-answering motivated by generic drug assessment. [^3]\n\nAn FDA Adverse Event Reporting System case series included reports of symptomatic hypophosphatemia that occurred after both single and multiple infusions of ferric carboxymaltose injection and resulted in hospitalizations. [^4]\n\nChronic hypophosphatemia associated with ferric carboxymaltose can also lead to osteomalacia (bone softening) and fractures. [^5]\n\nFerric carboxymaltose is an iron replacement therapy originally approved in 2013 for treating iron deficiency anemia in patients 1 year and older who cannot tolerate oral iron. [^6]\n\nThe delay is ostensibly to give more time for the government's internal review of the pill's safety data. [^7]\n\nThe lawsuit, brought by Florida and Texas, challenges the FDA's regulation of the abortion pill and its safety data. [^8]\n\nExperiments across proprietary and open-weight models revealed substantial gaps in factual grounding, long-context retrieval, and safe refusal behavior. [^9]\n\nThe benchmark was constructed in collaboration with FDA regulatory assessors to ensure high-quality, expert-curated QA examples. [^10]\n\nThe new hearing date of December 1 is after the November midterm elections. [^11]",
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