BioCentury
ARTICLE | Clinical News

Protelos strontium ranelate regulatory update

March 26, 2012 7:00 AM UTC

EMA's CHMP concluded the benefits of Servier's Osseor/Protelos strontium ranelate continue to outweigh the risk, but recommended the drug's label be contraindicated in patients with venous thromboembolism or who are temporarily or permanently immobilized. CHMP also concluded that patients should be made aware of time-to-onset and likely signs of severe skin reactions. Protelos, which consists of 2 atoms of stable strontium and ranelic acid, is marketed in the EU to treat postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures. ...