Australia's TGA issues warning on denosumab and QT prolongation

In Australia, product Information documents for US biotech major Amgen’s (Nasdaq: AMGN) denosumab have been updated regarding the potential risk of QT interval prolongation associated with hypocalcemia.

This issue was identified during an assessment of adverse event reports relating to this medicine by Australia’s Therapeutic Goods Administration (TGA).

Denosumab is a fully human monoclonal antibody to the receptor activator of nuclear factor-κB ligand (RANKL) that blocks its binding to receptor activator of nuclear factor-κB (RANK), inhibiting the development and activity of osteoclasts, decreasing bone resorption, and increasing bone density.