More Than 2000 Pradaxa Lawsuits Have Been Filed Against Boehringer, And A Company Official Has Admitted That More Than 1400 Patients Bled To Death
UPDATE: Boehringer Pays $650 Million to End Blood Thinner Cases (5/28/14, Bloomberg)
Boehringer Ingelheim GmbH, the German family-owned drugmaker, agreed to pay $650 million to settle the majority of lawsuits filed over its blood-thinning drug Pradaxa, which has been linked to more than 500 patient deaths....
Earlier this month the drug company Boehringer Ingelheim said a new analysis of a company-funded study of 18,000-patients, known as RE-LY -- which the company 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.
According to a May 14, 2014 news article, "Boehringer Says New Bleeding Cases Found in Pradaxa Study":
Any correction to the original study, which was published in the New England Journal of Medicine in September 2009, would have to come from the researchers, Smith said. If a correction is made, it would be the second to the trial.
The researchers issued a correction in November 2010, saying they identified several additional events when they were conducting “routine clinical site closure visits.” A broader review at the time found 81 more complications, including clots, major bleeding, a stroke and four heart attacks, in 80 patients.
Further, from that same May 2014 Bloomberg article:
Boehringer faces more than 2,000 lawsuits involving Pradaxa, a treatment used to prevent strokes in patients who suffer from atrial fibrillation, a heart-rhythm disorder. The Ingelheim, Germany-based company conducted the review after plaintiff’s attorneys uncovered patients who experienced major bleeding and died while taking Pradaxa who weren’t included in the original trial results....
More than 1,400 patients bled to death while taking the medicine through Oct. 2, 2013, Andreas Clemens, an executive who oversaw the drug, said in a deposition unsealed Feb. 19 as part of the lawsuits.
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Also in mid-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.
From this Pradaxa safety update item, "FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin", issued on May 13, 2014:
FDA completed an observational cohort study of Medicare beneficiaries that compared Pradaxa (dabigatran) and warfarin for rates of ischemic stroke, intracranial hemorrhage, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The study included new users of Pradaxa and warfarin who had received a diagnosis of atrial fibrillation (AF) in the 6 months prior to the first dispensing of medication....
The larger Medicare study, which assessed a relatively older population (all over 65 years of age) found that Pradaxa was associated with an increased risk of major GI bleeding compared to warfarin. This finding is consistent with the RE-LY trial which showed that the risk of GI bleeding with Pradaxa compared to warfarin increased with age.
We will continue to monitor the FDA regulatory realm, the products liability litigation, and the medical research literature for developments about the safety issues surrounding Pradaxa, especially those involving cases of gastrointestinal (GI) bleeding adverse drug events, some which have been fatal to patients.