Other safety alerts
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| European Union: European Medicines Agency confirms positive benefit-risk balance of Protelos／Osseor (strontium ranelate), but recommends new contraindications and revised warnings |
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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has finalised a review of Protelos and Osseor (strontium ranelate), from Les Laboratoires Servier. The Committee concluded that these medicines remain an important treatment for women with osteoporosis, but that changes to the prescribing advice are necessary to better manage associated risks. These medicines are no longer recommended for use in immobilised patients or patients with venous thromboembolism (VTE) and warnings in product information should be updated regarding serious skin reactions.
Protelos and Osseor are indicated for the treatment of osteoporosis in postmenopausal women to reduce the risk of broken bones in the hip and spine.
Venous thromboembolism (VTE) and severe skin reactions are known risks of these medicines and have been kept under close review by the CHMP. The risk of VTE was identified in clinical trials and the risk of severe skin reactions, such as drug rash with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) had been reported post marketing. Information on these risks had been included in the product information as warnings or listed as reported side effects.
The CHMP has reviewed all available data on the safety of Protelos and Osseor. The data show that the risk of VTE is higher in patients with a history of VTE, as well as in patients who are temporarily or permanently immobilised. The number of cases of VTE in elderly patients is also shown to be higher with Protelos and Osseor compared with placebo.
The data also show that the incidence rate of serious skin reactions such as DRESS, SJS and TEN is low and no possible mechanism of action has been identified so far. Because the best results in managing these conditions come from early diagnosis and immediate discontinuation of any suspect drug, it is very important that doctors and patients are alert to the time-to-onset and signs and symptoms of these conditions.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/03/news_detail_001471.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there is one registered product Protos Granules For Oral Suspension 2g, (HK-53835) containing strontium ranelate which is a prescription medicine. In view of the recommendation of the EMA, a letter to healthcare professionals will be issued and the matter will be discussed in the coming meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, March 17, 2012
Issued at HKT 12:00
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