In an investigation by The BMJ, Deborah Cohen finds that recommendations for use of new generation oral anticoagulants may be flawed because regulators did not see evidence showing that monitoring drug plasma levels could improve safety.
Feature: How the drug company withheld important analyses An investigation shows how the manufacturers of a blockbuster anticoagulant stroke drug withheld from the regulators important analyses regarding how to use the drug as safely and effectively as possible.
Feature: Concerns over data in key dabigatran trial Deborah Cohen considers the evidence that there may be a higher risk of bleeding with dabigatran than has previously been reported.
Analysis: Bleeding, and the regulators Thomas J Moore and colleagues highlight the differences in how US and European regulators managed the safety problems of the new anticoagulant dabigatran and ask both to think again and mandate plasma monitoring of dabigatran.
Editorial: The trouble with dabigatran Doctors and patients must tread carefully through emerging risks.
Key documents
These are some of the key documents referred to in the investigation, showing modelling which Boehringer Ingelheim carried out on Dabigatran.
- An Idea for a Mid to Long Term Strategy for Pradaxa
- Impact of Dabigatran Dose Adjustment on Clinical Outcome in AF Patients., A Clinical Trial Simulation Analysis
- Potential Mid to Long Term Strategy for Pradaxa in SPAF
- An Idea for a Mid to Long Term Strategy for Pradaxa, showing EMA range comparisons