EMEA adds warnings in the prescribing information of Strontium Ranelate (Protelos)

On November 16, 2007, the European Medicine Agency (EMEA), the European's equivalent to the Saudi Food and Drug Authority (SFDA), agrees on the inclusion of warnings concerning the risk of severe hypersensitivity reactions in the prescribing and patient information for strontium ranelate, as an urgent measure .

Strontium ranelate (Protelos) is used for treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.

Up to now, 16 cases of 'drug rash with eosinophilia and systemic symptoms' (DRESS) in patients treated with Protelos, two of which were fatal, have been reported to the EMEA. DRESS 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.

Having assessed the newly available data, EMEA has agreed that the product information be provisionally updated in a rapid procedure to include warnings on severe hypersensitivity syndromes, including DRESS and Stevens Johnson-Syndrome, in the prescribing and patient information, as an urgent measure.

Action that Healthcare Professional should follow:

• Healthcare providers should advice patients to stop treatment with Protelos when a rash, swelling of the face, tongue or throat, difficulty in breathing or swallowing, occurs and to seek medical advice
• Once the treatment has been stopped, Protelos should not be re-introduced

Report Adverse Drug Reactions to the Saudi FDA:

Public and health professionals are encouraged to report adverse drug reactions to the National Pharmacovigilance Center on the Internet at: