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Denosumab (Prolia°) and osteoporosis: an increasingly unfavourable harm-benefit balance

Reports of sometimes serious adverse effects tilt the harm-benefit balance of denosumab in the treatment of osteoporosis.

Denosumab is authorised in some cases of osteoporosis and bone metastases. 

As expected from the pre-market evaluation of denosumab, reports of adverse reactions related to disruption of the immune system attributed to denosumab are accumulating. To date, several thousand cases had been recorded worldwide. Before and after its commercialisation, an increased risk of deep infections (heart, brain, bone, skin, blood) was observed with denosumab as well as an increase in cancers. Severe hypersensitivities, and sometimes serious or even fatal autoimmune disorders, have been observed.

These disruptions to the immune system are in addition to various known adverse effects of denosumab: back pain, muscle and bone pain; hypercholesterolemia, hypocalcaemia, osteonecrosis; bone disorders and atypical fractures. There is also a risk of multiple vertebral fractures when treatment is halted.

The harm-benefit balance of denosumab is clearly unfavourable in osteoporosis. It is better not to start such a treatment, which also avoids any problems related to halting it.

When denosumab is discontinued, French recommendations – with little supporting evidence at present – are to offer a bisphosphonate for 6 to 12 months.

©Prescrire 1 November 2018

"Denosumab: immune dysfunction" Prescrire Int 2018; 27 (198): 268-269. (Pdf, subscribers only).

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See also:

Towards better patient care:
drugs to avoid in 2018
Prescrire Int 2018;
27 (192) 107-8.
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Denosumab and male
osteoporosis. Do not use
in men (or in women)
Prescrire Int 2016;
25 (168): 36.
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Denosumab: limited efficacy
in fracture prevention,
too many adverse effects
(June 2011)