Europe wants more restrictions on Servier's Protelos

France's Servier is under renewed scrutiny from European regulators. Citing heart risks, a committee of the European Medicines Agency (EMA) has recommended further restrictions for Protelos, an osteoporosis drug made by Servier, the company at the center of a scandal in France for off-label use of its Mediator diabetes drug, which was also tied to heart risks.

A routine follow-up review of Protelos led EMA to suggest restricting Protelos only for the treatment of severe osteoporosis in postmenopausal women and men at increased risk for fracture and discontinuing use in patients with a history of ischemic heart disease such as angina, as well as peripheral arterial disease or cerebrovascular disease or untreated hypertension, PharmaTimes reports. 

The EMA said, "the data were of concern given other serious risks (blood clots and rare serious skin reactions) that were identified in a previous EMA review in 2012." The recommendation has been passed along to EMA's Committee for Medicinal Products for Human Use, which will discuss it next week. Back in 2007, Protelos was linked to a severe and potentially fatal skin reaction, and the EMA at the time ordered the company to correct "flaws" found in its adverse event tracking. 

For years now, French drugmaker Servier and its diabetes drug Mediator have been central to a scandal that has rocked drug regulators in Europe. Last month, France took the unusual step of launching a manslaughter investigation into its own drug approval agency looking into why the ANSM failed for years to remove Mediator from the market, when other jurisdictions had already yanked it over health concerns. Mediator was often prescribed, off-label, for weight loss. The company's founder is already facing manslaughter charges. 

- here's the PharmaTimes story
- see the EMA recommendation (PDF)

 

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