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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 »

Australian Health Regulators Question Benefit of Xarelto Monitoring

Foreign regulators in Australia completed a review of a new class or oral anticoagulants – Xarelto, Pradaxa and Eliquis – finding little evidence to support the benefits of routine blood monitoring in patients. Prescriptions for these blood thinning medications have skyrocketed in recent years, primarily because of their dosing convenience, allowing... Read more »

Research Misconduct Involving Xarelto Goes Unreported

JAMA Internal Medicine recently published a study by Charles Seife that highlights a profound flaw in how consumers obtain information about clinical drug trials. According to the New York University professor, only 4 percent of questionable practices or violations discovered by health regulators during pharmaceutical trials ever reaches the public.... Read more »

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

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 »