Protelos®
Active ingredient: Strontium ranelate
Marketing authorisation holder: Les Laboratoires Servier
Availability: Private Sector
Variations: Subsequent to assessment of Periodic Safety Update Report (PSUR) by the CHMP, the MAH was
requested to include bone marrow failure as an undesirable effect. From post-marketing surveillance, the MAH
also included lymphadenopathy and eosinophilia in the adverse effect list. This is because 63 cases of
oesinophilia and 25 cases of lymphadenopathy have been reported cumulatively. From the data provided, it was
observed that the majority of cases occurred upon initiation of treatment and as part of hypersensitivity reaction.
A cumulative review of cytopenic disorders was submitted for the PSUR. This summed up to 46 case reports
(53 events) relating to cytopenic blood disorders from its initial marketing authorisation. Some of these cases (a
few in association with skin reactions) showed a suspected causal relationship to strontium ranelate.
Reference: European Medicines Agency. Protelos. [online]. 2011 Mar 4 [cited 2011 July 30]; Available from: URL:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000560/human_med_000999.jsp&murl=menus/medicine
s/medicines.jsp&mid=WC0b01ac058001d124