According to the EU, Protelos can have deadly effects in case of allergies. In Italy it is used by 100,000 women. At the heart of the case is the Servier company, which has already been accused of another drug
Side effects discovered during trials and hidden in order to market a medicine without delays and problems. The French pharmaceutical company Servier has come under attack in its country for a dossier from the EMEA, the European drug agency, in which it is accused of having "hid from the authorities some cases of serious side effects", which according to the accusations, if known, could have called into question the marketing of Protelos.
It is a drug that is also marketed in Italy and is used for the treatment of osteoporosis, doctors prescribe it to prevent hip and spine fractures. The active ingredient behind Protelos is strontium ranelate, which is also present in a different branded product sold in pharmacies, Osseor. In our country, 625,000 packs of the first and 739,000 of the second are sold every year. It is estimated that at least 100,000 women use it.
Already in 2007, the EMEA had also done an in-depth study on the adverse reactions to strontium ranelate, given that since the 2004 marketing there had been cases of Dress syndrome, a serious form of skin rash of allergic origin. "The risks associated with this product were known but side effects are one thing, another is if we realized the existence of problems before launching and kept quiet. It would be a very serious fact, which must end up before a court.
Hiding damage during experimentation to market a medicine without problems is a practice that unfortunately has precedents. The same thing happened for certain non-steroidal anti-inflammatories". To speak is Salvatore Minisola, full professor of Internal Medicine at Sapienza and president of Siommms, the Italian Osteoporosis Society. It is also thanks to an investigation by the newspaper Liberation that a new impropriety committed by Servier is coming to light in France, who defends himself by denying the accusations and claiming that everything is in order. However, the pharmaceutical company has a very heavy precedent: it ended up in the cyclone for another drug, Mediator, a that would have caused between 500 and 2 thousand deaths and was withdrawn from the market in 2009. In recent days in France, two victims' associations have announced that they are ready to present claims for damages to the company. Protelos and Osseor are not the most used drugs in our country against osteoporosis. "Bisphosphonates are prescribed more," explains Minisola. According to a study by the EMEA, strontium ranelate was on the market in three years, between 2004 and 2007, resulted in 16 severe cases of Dress syndrome, 2 of which resulted in death. The European agency came to the conclusion that "doctors and patients should be warned of the risk". An emergency procedure was initiated to introduce the warning.
