The bone disease drug Prolia has a new boxed warning, the FDA's most prominent warning, because of an increased risk of severe hypocalcemia among chronic kidney disease patients.
The new warning follows the FDA's review of CMS studies and other data to assess Prolia patients' risk of developing severe hypocalcemia, or very low blood calcium levels that can lead to hospitalization and death.
Severe hypocalcemia can cause "confusion, seizures, irregular heart rhythm, fainting, face twitching, uncontrolled muscle spasms [and] weakness," the FDA said Jan. 19. The risk is highest among patients on dialysis.
Prolia (denosumab) is an monoclonal antibody first approved in 2010 for postmenopausal women with osteoporosis with a high risk for bone fracture. The FDA later added other approved indications for the medication that helps prevent cells from breaking down bones.
In a statement about the new boxed warning, the agency said healthcare professionals should assess patients' kidney function and weigh the risk of severe hypocalcemia with Prolia against alternative treatments for osteoporosis.