Strontium ranelate (Protelos) and severe allergic reactions
admin November 20th, 2007
The MHRA have responded to the European Medicines Agency statement on strontium ranelate:
Women taking Protelos should be alert to the risk of severe allergic reactions and if they develop a rash, they should stop taking the medicine and consult their doctor immediately. Once Protelos treatment has been stopped it should not be re-introduced.
The EMEA press release is here (PDF). The nature of the reaction is described:
Up to now, 16 cases of ‘drug rash with eosinophilia and systemic symptoms (DRESS)’ in patients treated with Protelos/Osseor, two of which were fatal, have been reported to the EMEA, following a total of around 570,000 patient-years of worldwide exposure. DRESS is a serious and life-threatening condition. The reported serious reactions started within 3 to 6 weeks of the initiation of the treatment, with skin rash, accompanied by a fever, swollen glands, increased numbers of white cells in the blood and effects on the liver, kidneys and lung.
Bottom line: Strontium ranelate has been associated with severe allergic reactions to which prescribers and users should be alert to. Women taking strontium ranelate who develop any form of rash should stop treatment immediately and seek medical advice.