On the front of its Business Day section, the New York Times 
(11/3, B1, Thomas, Subscription Publication) reported Boehringer Ingelheim's blockbuster anticlotting drug Pradaxa (dabigatran) is producing deaths from unstoppable bleeding, and critics are taking aim at the FDA "because it allowed a potentially dangerous drug to be sold without an option for reversing its effects." Pradaxa has been "linked to more than 500 deaths" in the US. Conversely, the FDA on Friday released the results of a Safety Review, which found Pradaxa "did not show a higher risk of bleeding than for patients taking warfarin." Although Boehringer Ingelheim recommends "testing patients' kidney function before prescribing Pradaxa and notes that the risk of bleeding increases with age," critics contend that until "an antidote is found," use of the drug should be "limited." Meanwhile, more than "100 lawsuits have been filed in federal courts and lawyers say thousands more are expected."
(11/3, B1, Thomas, Subscription Publication) reported Boehringer Ingelheim's blockbuster anticlotting drug Pradaxa (dabigatran) is producing deaths from unstoppable bleeding, and critics are taking aim at the FDA "because it allowed a potentially dangerous drug to be sold without an option for reversing its effects." Pradaxa has been "linked to more than 500 deaths" in the US. Conversely, the FDA on Friday released the results of a Safety Review, which found Pradaxa "did not show a higher risk of bleeding than for patients taking warfarin." Although Boehringer Ingelheim recommends "testing patients' kidney function before prescribing Pradaxa and notes that the risk of bleeding increases with age," critics contend that until "an antidote is found," use of the drug should be "limited." Meanwhile, more than "100 lawsuits have been filed in federal courts and lawyers say thousands more are expected."
Also covering the FDA's safety review results were Reuters (11/3, Pierson) and MedPage Today (11/4, Neale). Separately, MedPage Today (11/5, Gever) noted that as "part of its ongoing safety review of Pradaxa," the FDA said it is "conducting two additional protocol-based observational assessments."
(11/3, Pierson) and MedPage Today (11/4, Neale). Separately, MedPage Today (11/5, Gever) noted that as "part of its ongoing safety review of Pradaxa," the FDA said it is "conducting two additional protocol-based observational assessments."
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