Bloomberg News

Boehringer Confirms Pradaxa Drug’s Safety After Patient Deaths

November 02, 2011

Nov. 2 (Bloomberg) -- Boehringer Ingelheim GmbH said the safety and effectiveness of its blood-thinner Pradaxa remains unchanged after reports that some patients taking the drug died.

Serious and fatal bleeding can occur with all blood- thinners, including Pradaxa, Reinhard Malin, a spokesman for the Ingelheim, Germany-based company, said by phone today. Though the number of deaths among Pradaxa patients hasn’t been verified, it’s likely in the range of 50 people, he said.

Boehringer received approval in Europe this year and in the U.S. last year to sell Pradaxa for patients with atrial fibrillation, an irregular heartbeat that can increase the likelihood of a stroke. Pradaxa was more effective than the previous standard of care, warfarin, in a study of about 18,000 patients. The reported number of deaths so far is fewer than would have been expected from the results in the trial, called RE-LY, Malin said.

“It can be estimated that a significant number of fatal or disabling strokes has been prevented in the approximately 450,000 atrial fibrillation patients currently on Pradaxa,” Boehringer said in an e-mailed statement today.

Die Zeit newspaper reported earlier today that fatalities had occurred among Pradaxa patients, citing Boehringer, and said the company is probing individual cases. The drugmaker last week cautioned doctors to conduct regular kidney tests in patients over 75 years and in those with kidney conditions, the newspaper said.

--Editors: Kristen Hallam, Jerrold Colten

To contact the reporter on this story: Naomi Kresge in Berlin at nkresge@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net


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