FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Boehringer Wins Again as California Judge Tosses Pradaxa Lawsuit

Feb. 11, 2019
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A California judge ruled in Boehringer Ingelheim’s favor in another court case involving its blockbuster blood thinner Pradaxa (dabigatran) and allegations of fraud and failure to warn about the drug’s risks.

The lawsuit alleged that the drugmaker should be held responsible for failing to warn prescribers about drug risks, including that no reversal agent existed to stop or control bleeding in patients. It also blamed the company for failing to inform doctors that the medication has a narrow therapeutic window and should be dose adjusted, among other grievances.

During testimony, the prescribing doctor in the case argued that none of the additional risk information or documents he was presented with would have changed his decision to prescribe Pradaxa to the patient. If the label had directed him to monitor the patient while they were prescribed the drug, he would have done so, he said.

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