Patients are raising concerns about a lack of informed consent over the nation's most popular osteoporosis drug. They say not enough of them are being adequately informed of side effects or complications when coming-off the drug.
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00:00Margaret Rynes had osteonecrosis of the jaw for two years, a painful condition that involves
00:08the death of bone cells due to decreased blood flow.
00:11The pain will come on suddenly and it's so severe, all you want to do is go and lie down.
00:19It's a side effect of the osteoporosis medication she was taking, but her specialist hadn't
00:24warned her.
00:26Osteoporosis reduces bone mass and density, making them fragile.
00:30Prolia or denosumab works by blocking cells that cause the bone loss.
00:34It's given by injection every six months, but a late or skipped dose can make symptoms
00:39return, sometimes worse than before.
00:42There is a small but significant risk of multiple spine fractures in patients who stop prolia
00:50without any further preventative measures.
00:55He co-authored a report finding most patients weren't offered those preventative measures.
01:00Some patients say it's an ongoing issue and the advice gap means they weren't able to
01:04give informed consent.
01:06We're just being told the side effects are rare, you can stop taking at any time, my
01:11mother is on it, if you don't take it you will break a hip and die.
01:16I think it's very important that anyone who prescribes or deprescribes a drug for a patient
01:21has this conversation with them.
01:24Patients want the regulator to add a black box warning to prolia, something that's already
01:28happened in the US.
01:29But it and the drugs manufacturer Amgen say warnings are already listed on the product
01:34information leaflet.
01:36The RACGP insists prolia is safe and effective and warns injury from osteoporosis can be
01:42deadly.