Following the filing of complaints from four families of deceased patients treated with Pradaxa, the Boehringer Ingelheim laboratory and the ANSM defend the new anticoagulant.
The Boehringer Ingelheim laboratory defends itself. This morning, a complaint for manslaughter was filed by the family of a deceased patient treated by Pradaxa and three more will be in the coming days. The complaint targets the pharmaceutical laboratory but also the National Medicines Safety Agency (ANSM), which the complainants accuse of having disregarded the principles of precaution and prevention.
To respond to these attacks, the German group which produces the anticoagulant first of all wished to recall that Pradaxa obtained its Marketing Authorization (MA) centralized in the European Union in March 2008 in its surgical indication. in prevention of venous thromboembolic accidents after hip or knee prosthesis. He then obtained an extension of MA in the prevention of stroke and systemic embolism linked to atrial fibrillation associated with one or more risk factors. Pradaxa had indeed proven its superiority compared to the reference treatment, the antivitamins K.
A known risk of bleeding
In addition, “the new oral anticoagulants, of which Pradaxa® is a part and like any anticoagulant, are associated, because of the desired therapeutic effect, anticoagulation, with a risk of bleeding”, underlines Boehringer Ingelheim. The risk was therefore known and it requires “strict compliance with the legal notices and the prescription conditions of the products.” In addition, in its defense, the pharmaceutical group argues that in terms of hemorrhagic risk, the new oral anticoagulants are on a par with the old molecules that are the K antivitamins.
No antidote but an emergency protocol
To deal with emergency situations, Boehringer Ingelheim indicates “that a treatment protocol has been defined”. “And if certain cases of hemorrhage can evolve dramatically, recognizes the laboratory, these cases are to be put in perspective with the 4,000 deaths and the 17,000 hospitalizations caused each year by antivitamins K in France. On the other hand, the German group does not respond to another accusation brought by the lawyers. They point out that Pradaxa is most often prescribed to the elderly and that there is a lack of scientific data concerning the effect of this drug on this population.
For its part, the ANSM also reacted through the voice of its director Dominique Maraninchi, on the sidelines of a press conference on the flu. He reiterated that “anticoagulants were valuable drugs despite their known and monitored bleeding risk”. He was also concerned about the considerable risk to patients if the media coverage of the case “created a wind of panic” conducive to treatment interruptions.
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