While the Servier laboratory is accused of having lied to the health authorities to obtain the marketing of the Mediator, the newspaper Release reveals an embarrassing new affair for Servier. The laboratory is said to have concealed from health authorities the serious side effects of an osteoporosis drug, Protelos, launched in 2004.
These allegations of the Liberation newspaper are based on a 2010 report produced by the French Agency for the Safety of Health Products (Afssaps) at the request of the European Medicines Agency (EMA).
According to the document, which was obtained Release, Servier would not have declared the death of two patients on whom serious side effects had been noted. And this “oversight” is only one element of a series of “flagrant cases of omission” whose objective was to diminish the importance of “adverse effects”, among which: “acute renal failure” and Dress, a drug hypersensitivity syndrome.
The report also notes serious shortcomings in detecting patients who have had side effects in countries such as Portugal, Spain and Cyprus.
These malfunctions in the pharmacovigilance system of the Servier laboratory could fuel the legal case since the EMA does not rule out legal action against the Servier laboratory.
