Pradaxa: why families are complaining

“A hemorrhage under Pradaxa is an open tap! We do not have the means to anticipate it, and we have no antidote ”protested Nathalie Dallard, nurse, who lost her 81-year-old mother a year ago to the consequences of blood loss. The latter, who lived in Ardèche, had been treated with this new generation anticoagulant (NACO) for a month and a half for heart rhythm disorders. “This drug must be withdrawn, that is why we are going to file a complaint against the Boehringer Ingelheim laboratory and against the National Medicines Safety Agency (ANSM), and that we are going to create an association to help victims . “

Listen to Nathalie Dallart, nurse, president of the association Aid to the victims of Pradaxa. ” If we file a complaint, it is to avoid other victims, the ANSM must withdraw this drug now. “

In the Parisian offices of lawyers Philippe Courtois and Jean-Christophe Coubris, another family filed a complaint against the laboratory and the ANSM for manslaughter. “Yves Cueff, aged 70, died on February 15 at the Poissy hospital of an” uncontrollable hemorrhage “three days after a knee operation which had” proceeded normally “, according to the medical report, a exposed Me Philippe Courtois. The complaint is dated October 3 and was registered with the Paris prosecutor’s office. So far, four complaints have been filed or are in the process of being filed, but the two lawyers said they have been contacted by other potential complainants.

What are the arguments put forward by the complainants? “There is no antidote, or specific treatment of proven efficacy in the event of a bleeding accident related to the action of these drugs”, while “the occurrence of a bleeding under AVK is absorbable by the administration of vitamin K ”. Why did the company market this drug without an antidote? asked the lawyers, who presented to the press a video sent in September to doctors by the laboratory, where it is explained that antidotes, “under development”, are expected for 2014.

Listen to Me Jean-Christophe Coubris, counsel for the plaintiffs. ” The laboratory has been working on this anticoagulant for 15 years, it could have been concerned earlier about this antidote problem. “

Why blame the ANSM? In France, national pharmacovigilance monitoring has been put in place since these NACOs were put on the market. The next progress report in the Pharmacovigilance Technical Committee is scheduled for next November. It will concern Pradaxa and Xarelto. “The pharmacovigilance system worked but we only opened the umbrella, we did not make the right decisions,” said Me Coubris. The Agency should have called into question the studies presented by the laboratory “which seem concealed to us”. The molecule “has not been studied enough, especially in the most fragile, elderly or kidney patients. We shouldn’t give them Pradaxa, insisted the lawyer. Seniors “are very poorly represented in the studies, although it is to them that most of this anticoagulant has been prescribed. “

And why are the complaints not aimed at prescribers? “Although some seem to us extremely light in their attitude, we leave it to the prosecutor to extend or not the prosecution to prescribers, said Jean-Christophe Coubris who also pointed out the lack of independent information provided to doctors.
Last clarification from the lawyer, “our objective is not to create a wave of panic, people treated with these new anticoagulants should not spontaneously stop their treatment, in case of doubt, they should go to their doctor. ”

“Boehringer Ingelheim is obviously at the disposal of the authorities who will conduct the investigations and with which the laboratory will actively collaborate,” announced in a press release the French subsidiary of the laboratory which markets Pradaxa.

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