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.
The so-called boxed warning, issued on Friday, comes after the health regulator in 2022 started a review into the risk of very low blood calcium in patients with advanced chronic kidney disease, particularly ones on dialysis, and Prolia. The FDA reviewed 25 cases between July 2010 through May 2021 during the investigation.
Discover how neurology specialty drugs are expected to increase hospital pharmaceutical spend by 3.42 percent in 2024 and three of the most expensive drugs for hospitals.