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FDA Accused of Lax Oversight in Pradaxa Approval Process

A new report from the Project on Government Oversight (POGO) includes serious criticisms of the FDA and the process through which it approved Pradaxa, Boehringer Ingelheim’s widely used, yet highly controversial anticoagulant drug. The comprehensive review of Pradaxa’s path to the American market accuses the regulatory agency of being “lax,... Read more »

Monitoring, Dosing Adjustments could Minimize Pradaxa Bleeding Events, Investigation Finds

Pradaxa package
An investigation by Deborah Cohen of the British Medical Journal (BMJ) has revealed that Pradaxa manufacturer Boehringer Ingelheim may have withheld analyses that might have prevented some Pradaxa bleeding events. Monitoring and dosing adjustments could make use of the drug even safer and more effective, according to Cohen’s findings. However, the... Read more »