Protelos is a drug from Servier laboratories sold in France since 2006. It is prescribed to treatosteoporosis severe and helps reduce the risk of spinal and hip fractures.
Already in 2007 the European Medicines Agency (EMA) revealed that “Protelos triggered 16 cases of serious allergic reactions called Dress syndrome, including two fatal”.
Dress syndrome (Drug Rash with Eosinophilia and Systemic Symptoms) is manifested by a rash, fever, lymph nodes, an increase in certain white blood cells and damage to one or more organs: liver, kidney or lungs. The risk of heart attack is also increased, the doctors had already limited the prescription of Protelos.
In September 2011, the French Ministry of Health therefore decided to reduce the reimbursement conditions for this drug, due to an increased risk of phlebitis that it caused. Since then, Protelos has only been covered by health insurance for patients who do not have “risk factors for a venous thromboembolic event”.
A drug more dangerous than its competitors
According to the Parisian, the conclusions of the Council of State on the laboratory’s request are final. In its six-page judgment, the Council of State declares: “not only”, he believes “in substance, the transparency commission, responsible for regularly reassessing the benefit-risk ratio of each drug, has done well its work, but one can doubt the innovative character of this product: while the laboratory maintains that Protelos would constitute the treatment of osteoporosis the most effective among the various specialties available […], it does not appear from the documents in the file […] than […] the active principle of Protelos is said to be more effective on bone micro-architecture than its competitors ”.
The magistrates affirm that “the Protelos presents a risk profile more dangerous than its competitors. And to recall “venous thromboembolic events, the incidence of which has not decreased despite the pharmacological monitoring of which the specialty has been the subject and the risk of DRESS syndrome, a severe allergic reaction which can lead to death”.
The reimbursement rate will be maintained at 30%.
The French Agency for the Safety of Health Products (Afssaps) recommends that patients under Protelos who would experience a rash to immediately stop their treatment and seek medical attention immediately.
