FDA adds boxed warning to denosumab specific for patients with advanced CKD

FDA added a boxed warning to the osteoporosis drug denosumab (Prolia). The agency’s review of the drug indicated risks that warrant new prescribing information. For patients with chronic kidney disease (CKD)—especially those on dialysis or those with a concomitant diagnosis of mineral and bone disorder—FDA said they could develop severe hypocalcemia, or very low levels of calcium in the blood.

FDA is changing the label for denosumab to include a boxed warning to reflect the risk of hospitalization and even death for this group of patients.

Added information will provide advice to both patients and providers on strategies to curtail the risk of harm, including a recommendation to evaluate kidney function in patients before prescribing denosumab, emphasis on the importance of sufficient calcium and vitamin D intake for current users, and a recommendation for frequent monitoring of blood calcium levels for patients with advanced CKD.