The Servier Protelos be reviewed

The risk / benefit of Protelos, an osteoporosis drug Servier, be reviewed at the Commission authorization to market Sept. 29 because of "persistent and significant, serious side effects."
129 "serious adverse events" were recorded 3.3 million cases sold from April 2009 to March 2011, according to a report presented yesterday to the Technical Committee on Pharmacovigilance (CTPV). Following this meeting, the European Agency for Health Product Safety (AFSSAPS) decided to review the Commission's benefit / risk MA on September 29, said today.

Possible suspension of marketing authorization
"The persistence of serious side effects significantly, despite the warnings introduced in the summary of product characteristics has Afssaps, based on the analysis presented in CTPV take the opinion of the National Pharmacovigilance and September 27 reviewing data from the Commission on benefit / risk to the marketing authorization on September 29, "he said.
Once the opinion of the Commission for marketing authorization, will be CEO of the Afssaps, Dominique Maraninchi, to make a decision. Professor Maraninchi said September 7 that the analysis could lead to "a suspension of the authorization for the medicinal product, to be educated at European level."
Enhanced surveillance since 2007
"If the benefit to patients is greater than the risk for patients who will not hesitate one second to exit the drug, since it does not hesitate a second to do if it were a drug from another lab," he had for his part, said Health Minister Xavier Bertrand.
Protelos is used to treat postmenopausal osteoporosis, to reduce the risk of bone fractures. Allowed in all European Union countries, the drug is marketed in France since January 2006. Since 2007 it has been "enhanced surveillance, particularly because of the risk of venous thromboembolism and severe allergic reactions."