EMA backs Protelos and Osseor, but with warnings

19 March 2012

The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has finalized a review of Protelos and Osseor (strontium ranelate), from independent French drugmaker Laboratoires Servier. The Committee concluded that these drugs remain an important treatment for women with osteoporosis, but that changes to the prescribing advice are necessary to better manage associated risks, with the drug no longer to be recommended for certain patients.

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. The drugs were authorized via the European centralized procedure in September 2004.

The review of Protelos and Osseor was started following the publication of a study in France identifying 199 severe adverse reactions reported with these medicines from January 2006 to March 2009 (The Pharma Letter October 2, 2011). Around half of these were venous thromboembolism (VTE) events, and about a quarter related to skin reactions.

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