BMJ criticism of regulatory agencies and Boehringer regarding Pradaxa - Boehringer

The BMJ has published articles criticising Boehringer for withholding safety information on bleeding and the regulatory agencies for rushing to approve Pradaxa with its risks of serious bleeding. The BMJ articles call for prior blood testing of Pradaxa patients which could reduce fatal bleeding by 40%. However the lack of monitoring is a prime element of the Pradaxa sales pitch. Boehringer contests the allegations as biased and misleading and states that the issues have been reported to the FDA and that the FDA has carried out its own safety review on the drug and found it safe. The BMJ calls for lower doses of the drug.

Boehringer has paid $650 million in damages in some 4000 trials arising from Pradaxa safety and some of the evidence of serious bleeding came from evidence presented in those cases.

Boehringer stated that post-market data assessments from the FDA comparing the drug to warfarin reinforce the favourable risk/benefit profile shown in RE-LY trial.

See - "Boehringer Ingelheim withheld safety analyses on new anticoagulant, The BMJ investigation finds"- BMJ 2014;349:g4756 (Published 24 July 2014)