Intended for healthcare professionals

Rapid response to:

Analysis

Ten years too long: strontium ranelate, cardiac events, and the European Medicines Agency

BMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i5109 (Published 30 September 2016) Cite this as: BMJ 2016;354:i5109

Rapid Response:

Cessation of strontium ranelate supply

To our knowledge, there has been no response to our article1 from the European Medicines Agency (EMA), the manufacturer of strontium ranelate, Servier, or the academics involved in the phase 3 trials of strontium.

However, a news release on the Servier website dated 14 March 2017 states that Servier sent a letter on 10 February 2017 to the EMA notifying them that worldwide marketing and distribution of strontium ranelate will cease permanently in August 2017 for commercial reasons.2 Similar letters were sent to all countries worldwide where strontium is marketed.2 At least one Servier website states that the decision “is not related to a quality or safety issue”,3 although the Servier news release cites the restricted indication/limited use of strontium as a contributing factor.2 These prescribing restrictions were imposed because of safety concerns.1

On 2 May 2017, we were unable to find any information about the upcoming cessation of strontium distribution in broad searches of the internet nor on all websites we specifically searched: the EMA website, and the websites of national regulatory bodies for the UK, Ireland, France, Germany, Italy, Denmark, Sweden, the Netherlands, Hong Kong or Australia. Therefore, the imminent cessation of strontium supply may come as a surprise to many clinicians and patients. Regulatory bodies that have not yet done so should notify practitioners as soon as possible of this development, so that patients can consider other management options.

Given the manufacturer will be no longer distributing strontium ranelate, and that any benefit of strontium in fracture prevention is outweighed by the risks of cardiovascular events and venous thromboembolism,1 it seems timely and appropriate that the registration for strontium ranelate be withdrawn.

1. Bolland MJ, Grey A. Ten years too long: strontium ranelate, cardiac events, and the European Medicines Agency. BMJ 2016;354:i5109.
2. http://www.servier.com/content/cessation-marketing-protelososseor-extrac...
3. http://www.servier.com.au/products/protosdiscontinuation

Competing interests: No competing interests

08 May 2017
Mark J Bolland
Associate Professor
Andrew Grey
Department of Medicine, University of Auckland
Private Bag 92019, Auckland 1124