In October 2013, the families of four people treated by Pradaxa died have complained against the Boehringer-Ingelheim laboratory which markets this new generation anticoagulant (NACO) and the National Agency for the Safety of Medicines and Health Products (ANSM). The judgment has just been rendered: the complaint is dismissed.
The lawyer for the plaintiffs, Maître Gérard Courtois reacted to this information on RTL and affirmed that “his clients would consequently lodge a new complaint, with constitution of civil party, to obtain the designation of investigating judges despite this classification by the Paris prosecutor’s office ”.
“I find this decision hasty and aberrant”, commented Maître Gérard Courtois who recalls that “recently appeared in the United States of the elements tending to show that the study prior to the marketing of Pradaxa” had been truncated “” .
New anticoagulants (NOACs): dangerous drugs
Newer oral anticoagulants (NOACs) are medicines that prevent blood clots from forming in the blood vessels. They are prescribed in case of phlebitis, stroke or certain people who suffer from heart rhythm disturbances. NACOs were developed and marketed from 2008 in order to offer the same benefit (avoid the formation of blood clots) as older generation anticoagulants (antivitamin K or AVK), while allowing more freedom to prescribers. and patients, because they do not (theoretically) require mandatory biological monitoring, unlike older drugs.
Nevertheless, the medical biologists had already alerted in September the Minister of Health, Marisol Touraine, on the dangers of these treatments. They recalled that “the prescription of NOACs cause the same serious side effects (severe hemorrhages, even fatal) as VKA, with however a major difference: there is no antidote to neutralize the effect by case of hemorrhage ”. In their sights, Pradaxa, an oral anticoagulant manufactured by the German laboratory Boehringer Ingelheim, which began to make a lot of talk in Germany and the Benelux, because it caused internal bleeding sometimes fatal. The German laboratory had indeed declared that 256 deaths by hemorrhage in the world were potentially attributable to Pradaxa, since its launch in 2008.
NACOs in France
In 2012, among the 100,000 patients undergoing anticoagulant therapy, 57% were prescribed a first-line NOAC. And 35,000 patients were prescribed NOACs instead of their old treatment with VKA.
The National Medicines Safety Agency (ANSM) recalls on its website that “the medicines Eliquis (apixaban), Pradaxa (dabigatran), Xarelto (rivaroxaban) are new oral anticoagulants which, unlike vitamin K antagonists, do not require no biological monitoring. However, their use can be associated, as with any anticoagulant, with the occurrence of hemorrhagic complications, which are sometimes serious ”.
