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Protelos(Servier) indication for Osteoporosis to be updated by EMA

Read time: 1 mins
Last updated:19th Mar 2012
Published:19th Mar 2012
Source: Pharmawand
The EMA still views Protelos/Osseor (strontium ranelate) from Servier Labs as an "important treatment" for women with Osteoporosis and its benefit: risk profile remains favourable, but it is no longer to be recommended for certain patients,and warnings on serious skin reaction will be updated. Prescribers should no longer prescribe the treatment to patients with current venous thromboembolism (VTE) or a history of VTE, or to patients who are temporarily or permanently immobilised. Prescribers must also warn patients about the signs and symptoms of severe skin reactions and discontinue treatment in patients who develop DRESS (drug rash with eosinophilia and systemic syndrome), SJS (Stevens-Johnson syndrome) or TEN (toxic epidermal necrolysis). Treatment should not be re-started at any time in these patients. In addition, the product information will be updated.

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