More Than 2000 Pradaxa Lawsuits Have Been Filed Against Boehringer, And A Company Official Has Admitted That More Than 1400 Patients Bled To Death
SUMMARY: In May 2014 it was reported that a new analysis of a company-funded study of 18,000-patients, known as RE-LY — which the drug company Boehringer Ingelheim used to win FDA approval of its controversial blood thinner Pradaxa — turned up 22 “new” serious bleeding events that were not included in the original study report.
Also in May 2014 the FDA issued a follow-up to its Pradaxa Drug Safety Communication issued on November 2, 2012, and the FDA has reiterated that Pradaxa is associated with an increased risk of major gastrointestinal (GI) bleeding compared to warfarin.
We will continue to monitor the safety issues surrounding Pradaxa, especially those involving cases of gastrointestinal (GI) bleeding adverse drug events.
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