Denosumab is the active ingredient for Prolia as well as Xgeva, with Prolia being a treatment for osteoporosis and osteopenia, and Xgeva being a drug used for the prevention of skeletal-related events in adults with bone metastases from solid tumors. Both Prolia and Xgeva come from biotech pharmaceutical company Amgen Inc.
An emerging drug safety issue was recently addressed by Australia’s Therapeutic Goods Administration (TGA), and was initially identified by that drug regulator during an assessment of adverse event reports relating to denosumab (Prolia and Xgeva).
Specifically, there are some new apparent side effects of Prolia as well as Xgeva, QT interval prolongation and severe symptomatic hypocalcemia.
From this August 12, 2016 article, “Australia’s TGA issues warning on denosumab and QT prolongation”, published on the ThePharmaLetter(subscription required) website, we get this detailed information:
Product information update
Hypocalcemia is a known effect of denosumab and was already captured in the Product Information (PI). However, there was previously no reference to QT prolongation, which is a potentially life-threatening disorder, or to severe symptomatic hypocalcemia.
The following sections of the PI have been updated: [Precautions and Adverse Effects]….
This updated information has harmonized the Australian PIs with the European Union Summary of Product Characteristics for these products.
We will continue to monitor this emerging drug safety issue for Prolia and Xgeva, including to watch for any similar regulatory action by the FDA here in the US.
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