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Amgen Osteoporosis Drug Prolia Is Hit With FDA's Strictest Warning

The FDA said Amgen’s Prolia may lead to low levels of calcium, or hypocalcemia. The osteoporosis drug’s black box warning follows an FDA review of Centers for Medicare & Medicaid Services studies that found Prolia led to a significant increase in the risk of severe hypocalcemia compared to treatment with an older class of medicines. ....

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FDA Adds Boxed Warning to Denosumab (Prolia) for Severe Hypocalcemia

On January 19, 2024, the FDA announced the addition of a Boxed Warning to the labeling of denosumab (Prolia), citing evidence of an increased risk of severe hypocalcemia in patients with chronic kidney disease. ....

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