Bone health

Osteoporosis treatment withdrawn from market


Patients currently taking strontium ranelate (Protos) will be forced to switch to another osteoporosis treatment as the drug has been permanently discontinued.

The move follows warnings about the drug’s safety profile although pharmaceutical company Servier has said their decision ‘is not related to a quality or safety issue’.

The drug was removed from the PBS in August 2016 and only limited stock of the drug will be available beyond August 2017.

Professor Peter Ebeling, medical director of Osteoporosis Australia, told the limbic the numbers of women on Protos would have declined substantially since the drug lost PBS reimbursement.

However it had remained an option for women who were unable to tolerate oral bisphosphonates due to gastrointestinal effects or those ‘unrealistically concerned about the risk of jaw osteonecrosis’.

“It is important now for women to see their local doctors and if at continuing high risk for osteoporosis, to be considered for oral bisphosphonates, intravenous bisphosphonates or denosumab,” he said.

He said women without any recent fractures and out of the osteoporotic range (T score >-2.5) could be monitored off treatment although bone density would fall.

However most women would be able to access another effective treatment.

“Hormone replacement therapy is still available for women with menopausal symptoms, and the benefits outweigh the risks up to 59 years of age,” he said.

“Raloxifene is also an option to reduce spinal fractures in women at risk of breast cancer.”

Protos was contraindicated in immobilised patients and those with a current or past history of ischaemic heart disease, peripheral vascular disease, cerebrovascular disease, uncontrolled hypertension, venous thromboembolism or pulmonary embolism.

Caution was advised in patients with risk factors for cardiovascular events or venous thrombosis.

A black box warning added to the product in 2014 said Protos ‘should only be used when other medications for the treatment for osteoporosis are considered unsuitable’.

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