Protelos risk benefit profile in PMO questioned

The transparency committee at the French health authority, HASe has been investigating pharmacoviligence data on Protelos( strontium ranelate) from Servier to see if its risk benefit profile needs to change. The drug has been associated with hyperesenitivity reactions such as rash, eosinophilia , systemic syndromes (DRESS)(16 cases) and Stevens Johnson Syndrome. EMA was critical of the Servier pharmacovigilence system and Servier implemented an action plan. EMA now considers the risk benefit profile of Protelos as positive. HASe has decided that Protelos offers no medical benefit over other medications for post-menopausal osteoporosis considering that the drug has safety risks including VTE (50 cases) between 2009-2011. Its investigations are continuing. Servier is also facing investigations and court proceedings into its promotion in France of Mediator, a Type 2 Diabetes drug that was used off label for weight loss. The drug was banned in 2009.