Severe hypocalcaemia warning with osteoporosis drug
The adverse event typically occurs within weeks of starting denosumab therapy, regulators warn.
This article has been updated.
The US medicines regulator has slapped a boxed warning on the osteoporosis medication denosumab regarding the increased risk of severe hypocalcaemia in patients with advanced chronic kidney disease.
The safety alert, issued in mid-January, follows a US Food and Drug Administration (FDA) investigation into the risk of serious outcomes, including death and hospitalisation, in those with impaired renal function prescribed denosumab (Prolia).
“This warning and new labelling contains information to help reduce this risk, including appropriate patient selection for Prolia treatment, increased monitoring of blood calcium levels and other strategies,” it said.
