BMJ alleges Boehringer Ingelheim withheld Pradaxa dosing information from regulators
German family-owned drug major Boehringer Ingelheim has been accused of withholding ‘important analyses’ from regulators regarding its anticoagulant Pradaxa (dabigatran).
The British Medical Journal says Boehringer Ingelheim was not sufficiently forthcoming on potential benefits of monitoring the anticoagulant activity of Pradaxa and adjusting the dose to ensure the drug works safely and effectively as possible. It said: “recommendations for use of new-generation oral anticoagulants may be flawed because regulators did not see evidence showing that monitoring drug plasma levels could improve safety.”
The drug has been linked to several hundred patient deaths and the company has agreed to pay $650 million to settle most US law suits relating to Pradaxa.
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