The prestigious British Medical Journal accuses the Boehringer laboratory of withholding information about its drug Pradaxa. The German laboratory denies outright.
Preventing cardiovascular risks is no easy task. Taking pulse, regular blood tests … The drug Pradaxa, manufactured and marketed by the Boehringer laboratory “would avoid these daily precautions”, according to its manufacturer. However, the British medical journal The Bristish Medical Journal (BMJ) published a controversial investigation on Wednesday. It reveals that the laboratory withheld important safety information relating to the drug. “Misleading statements”, according to the German laboratory, which responded to these accusations the same evening in a press release.
Less risk of bleeding
Pradaxa is an oral anticoagulant on sale on the pharmaceutical market since 2008. Like other anticoagulants, it can cause bleeding complications which are sometimes serious. But according to the Boehringer laboratory’s sales argument, blood tests to prevent stroke would no longer be necessary thanks to the taking of this drug. The investigation of BMJShe believes that the German pharmaceutical industry has overlooked safety data. The newspaper accuses the laboratory of having concealed documents showing that a blood test would allow a 30 to 40% reduction in bleeding caused by taking this Naco (New oral anticoagulant). ” The BMJ discovered that doctors and regulatory authorities had never heard of these calculations, ”the journal said in a statement.
Health agencies alerted
Faced with these accusations, the German laboratory retaliated by publishing a press release Wednesday evening, in which it qualifies the remarks of the British magazine as “misleading statements”. He defends himself by arguing that “the characteristics of patients, such as age, state of renal function and the taking of certain drugs, are essential factors contributing to the risk of bleeding”. The American (FDA) and European (EMA) health agencies, which respectively gave the green light for the marketing of the drug in 2010 and 2011, claim to have been vigilant. Their approval of the sale of the drug based exclusively on the information provided by the laboratory, they indicate that they have followed the reports carefully. “We will take the necessary measures if new information comes to us,” the EMA said.
At the end of 2011, complaints of severe bleeding began to emerge in Europe, notes the BMJ. In France, 4 people died of hemorrhages following taking Pradaxa at the beginning of 2013. Their families decided to file a complaint for manslaughter. A scandal that the High Authority of Health had tried to temper, by recalling that “the Nacos represent only an alternative to the standard treatment”. To respond to the potential new controversy launched by the English journal, the Boehringer laboratory for its part recommends that patients “not stop their treatment without first talking to their doctor”.
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