english.prescrire.org > Spotlight > 100 most recent > Protelos° (strontium ranelate) ought to have been withdrawn from the market long ago


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Protelos° (strontium ranelate) ought to have been withdrawn from the market long ago

In early March 2017, drug company Servier announced that it would be withdrawing its strontium ranelate-based Protelos° from the market. This withdrawal comes after far too much foot-dragging, which was positive for the company but harmful for patients. Considering its efficacy, modest at best, and its disproportionate adverse effects, strontium ranelate ought to have been withdrawn from the market  long ago.

Prescrire follows and regularly updates the clinical evaluation data regarding drugs on the market for preventing fractures related to osteoporosis, including strontium ranelate (Protelos°), which was granted market authorisation in 2004.

Strontium ranelate's adverse effects profile quickly became apparent after it came onto the market, and grew steadily worse. Prescrire subscribers have been alerted since the mid-2000s that it is better to avoid using strontium ranelate.

Below is a selection of Prescrire's articles on this subject:
February 2017 – Towards better patient care. Drugs to avoid in 2017
Prescrire Int 2017: 26 (181): 108-1-108-11.
Strontium ranelate has only modest efficacy in the prevention of recurrent vertebral fractures. Yet its adverse effects include neuropsychiatric disorders, cardiovascular disorders (including venous thrombosis and pulmonary embolism, myocardial infarction and cardiovascular death), and hypersensitivity reactions including toxic epidermal necrolysis and DRESS (drug reaction with eosinophilia and systemic symptoms)
> Pdf, free

January 2015 - Strontium still authorised despite an unfavourable opinion of the European pharmacovigilance committee
Prescrire Int 2015; 24 (156): 15.
Strontium ranelate (Protelos°-Servier), a drug authorised in the European Union for severe osteoporosis, has at best only modest efficacy in secondary prevention of vertebral fractures. In stark contrast, it carries a risk of disproportionate adverse effects.
> Free

October 2013. Strontium: myocardial infarction
Prescrire International 2013; 22 (142): 244
This adds to an already burdensome adverse effect profile. Do not use strontium.
> Pdf, free

June 2013 - Strontium ranelate (Protelos°) for osteoporosis in men: more dangerous than beneficial
Prescrire Int 2013; 22 (139): 150.
Prevention of osteoporotic fractures in men should focus on non-drug measures, along with calcium and vitamin D supplementation if necessary. Strontium ranelate should be avoided because it is more dangerous than beneficial.
> Free

March 2012 - Osteoporosis : avoid strontium ranelate (Protelos°)
Prescrire Int 2012; 21 (125): 72.
Strontium ranelate should be avoided as a treatment for osteoporosis due to its disproportionate adverse effects.
> Free

June 2011 - Osteoporosis: strontium ranelate has too many adverse effects
Prescrire Int 2011; 20 (117): 155.
Strontium ranelate offers no therapeutic advantage compared to alendronic acid. Since its commercialisation in 2005, there has been more evidence of its adverse effects, and today, it is clear that patients should not be exposed to the harms associated with this drug.
> Free

October 2009 Strontium: confusion and hallucinations
Prescrire Int 2009; 18 (103): 216.
When added to the known risks of muscle damage, thromboembolism and hypersensitivity, these adverse effects make it difficult to justify the use of strontium ranelate, a drug that provides no demonstrated therapeutic advantage over bisphosphonates.
> Pdf, subscribers only

December 2005 - Strontium, postmenopausal osteoporosis: too many unknowns
Prescrire Int 2005; 14 (80): 207-211.
For postmenopausal women with osteoporosis, the only demonstrated benefit of strontium therapy is a lower incidence of new symptomatic vertebral fractures (secondary prevention), similar to that seen with alendronic acid. Other possible benefits remain to be demonstrated. The potential risks of this treatment (thromboembolism, and muscular, neurological and bone disorders) are poorly documented.
> Pdf, subscribers only

December 2005 - New from old?
Prescrire Int 2005; 14 (80): 211.
Strontium was first used to treat osteoporosis in the 1950s, before being abandoned. It's back now, dressed in new clothes (ranelic acid) and with an intriguing name. Although thousands of patients have been treated in clinical trials, no convincing evidence has emerged that strontium ranelate is any better than diphosphonates. In addition, the risks are poorly documented.
> Pdf, subscribers only

©Prescrire 1 April 2017