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Strontium ranelate gets reprieve from European regulator

The osteoporosis drug strontium ranelate has been given a last-minute reprieve by Europe’s medicines regulator, following months of speculation as to whether it would be withdrawn from the market.

European Medicines Agency (EMA) experts said strontium ranelate – marketed as Protelos in the UK – should continue to prescribed, albeit only in those patients who cannot use other approved treatments for the condition, and with careful monitoring for cardiovascular risk factors.

The decision comes after the EMA was advised to suspend the drug, owing to evidence it increases the risk of major cardiovascular events, as well as concerns that the restrictions placed on its use last year did not go far enough.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has now judged strontium ranelate does offer benefits to patients at high risk of fracture, while there is no evidence it increases the risk in people without a history of cardiovascular problems.

CHMP chair Tomas Salmonson said: ‘The CHMP considered that, for patients who have no alternative treatment, regular screening and monitoring to exclude cardiovascular disease will sufficiently reduce the risk identified by the [Pharmovigilance and Risk Assessment Committee] so that these patients can continue to have access to the medicine.’

Dr Jonathan Bayly, visiting professor at University of Derby and a former GP in Gloucestershire, said he was ‘puzzled’ by the agency’s decision after the PRAC subcommittee’s advice to withdraw its licence.

He said: ‘My point would be that contraindication or caution now exists for CVD and uncontrolled hypertension or risk factors for the same. This would apply to many elderly patients. That is precisely the population that strontium is/was often seen as useful for.

‘I would think that IV bisphosphonates or subcutaneous Denosumab would be more likely to be selected for those [patients] intolerant of oral bisphosphonates in the future as the cost is comparable to strontium and the dosing frequency of 6/12 or 12/12 is easier for the patient.’ 

But Dr Sally Hope, honarary research fellow in women’s health at the University of Oxford and a former GP, said: ‘I’m very relieved that EMA have allowed strontium to remain an option for some people. There are some patients who cannot tolerate any of the bisphosphonates, and then have a reaction with denosumab and cannot get [parathyroid hormone] under NICE guidelines, so this leaves a possible therapeutic window open for them.’

Fizz Thompson, clinical and operations director of the National Osteoporosis Society, said: ‘Considered against the potential for Protelos to be fully withdrawn, this is good news as it maintains a range of treatment options for people with osteoporosis. We would encourage people who are taking strontium who have not been assessed in the last year to speak to their GP about how this might impact them.’

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