Not only with dabigatran. Therapeutic excesses can condition bleeding risk and therapeutic limitation can increase thrombotic risk, especially when short-acting drugs such as the new oral anticoagulants are used. Hence, it is imperative to establish an appropriate method for monitoring new oral anticoagulants, setting levels of safety and effectiveness through periodic dosage and monitoring of their anticoagulant effects
More Questions Raised About Dabigatran — Physician’s First Watch
More Questions Raised About Dabigatran
By Larry Husten
Relying on new evidence along with previously disclosed data, an investigation in the BMJ casts doubt on the reliability of data supporting the anticoagulant dabigatran (Pradaxa).
The most important new accusation is that Boehringer Ingelheim "failed to share with regulators information about the potential benefits of monitoring anticoagulant activity and adjusting the dose to make sure the drug is working as safely and effectively as possible. The company also withheld analyses that calculated how many major bleeds dose adjustment could prevent."
Editorialists write that the articles raise "serious questions" about dabigatran. They say they're concerned about "potentially higher than reported bleeding risk; the possibility of undertreating or overtreating with fixed doses, especially in older patients and patients with changing renal function; the unknown value of monitoring dabigatran levels and adjusting the dose; and the lack of a specific reversal agent."
The editorialists "suggest a shared decision that balances patients' tolerance of unknown risks, their tolerance of routine laboratory monitoring and dose adjustment, and their risk of stroke."
Boehringer Ingelheim strongly disputes the accusations.