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EMA restricts use of Servier’s Protelos and Osseor

Osteoporosis drugs not to be used in patients with history of blood clots

Servier's osteoporosis treatments Protelos and Osseor (strontium ranelate) can no longer be used in immobilised patients or patients with a history of venous thromboembolism (VTE) after new recommendations from the European Medicines Agency (EMA).

Their labels have also been updated to include warnings of serious skin reactions following a safety review by the Agency's Committee for Medicinal Products for Human Use (CHMP), begun after a French study identified 199 severe adverse reactions reported with these medicines from January 2006 to March 2009.

About half of the reactions involved VTE, a blood clot that forms within a vein, and about a quarter related to skin reactions.

But despite the risk of side effects, the EMA said the medicines should still be available for other types of patients and stated Protelos and Osseor "remain an important treatment for women with osteoporosis" having demonstrated an ability to recreate bone mass.

In its review, the CHMP said the data showed incidents of VTE were higher in patients with a history of that condition, as well as in patients who are temporarily or permanently immobilised.

Elderly patients were also shown to be more at risk of contracting VTE after use of Protelos and Osseor compared with placebo.

VTE-related incidents include deep-vein thrombosis and pulmonary embolism and affect millions across Europe every year.

The data also demonstrated that incidents of three skin reactions - drug rash with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) - were all been recorded post-marketing.

A spokesperson for Servier told the UK's Daily Telegraph: "Servier acknowledge the revision to the use of strontium ranelate to include a contraindication for patients with current or previous venous thromboembolic events (VTE).

"This is a slight extension from a previous caution with strontium ranelate. This risk represents an additional risk of less than one per cent compared to a control group."

19th March 2012

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