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More than 2,000 Lawsuits Filed Against Boehringer Ingelheim over Pradaxa Blood-Thinning drug

Filed February 13th, 2014 Laurie

More than 2,000 lawsuits have been filed in the United States against Boehringer Ingelheim over its blockbuster blood-thinning drug Pradaxa, the drug maker admitted Thursday.

Boehringer confirmed that the number of cases reported Thursday by German newspaper Handelsblatt was accurate. Individuals who filed lawsuits against the company say Pradaxa caused them or their loved ones severe and sometimes fatal bleeding. The company also said the side effects of the drug had to be weighed against the very real risks, which are known. There is no antidote to Pradaxa, according to Reuters.

In a statement obtained by Reuters, Boehringer said it was confident that it could prove it had worked very carefully at researching, developing, and marketing Pradaxa.

Pradaxa was marketed as a promising new stroke-prevention drug for patients with atrial fibrillation that would replace the standard warfarin, which had been used for decades. The drug ended up causing internal bleeding in some elderly patients, however, Reuters reported.

On February 5, the New York Times (Times) reported that Boehringer Ingelheim was so concerned about the potential damage an internal research paper could do to drug sales that some employees pressured the author to revise it and suggested that it be quelled entirely.

A federal judge in Illinois who is overseeing the lawsuits, which allege Boehringer failed to properly warn patients about the risks of taking Pradaxa, decided to publicly release the documents, the Times reported.

Many of the documents released by Chief Judge David R. Herndon of the United States District Court in East St. Louis contradict Boehringer’s claim that Pradaxa does not require regular blood tests to ensure it is working, which was one of the drug’s main selling points. Some of the memos show that a certain segment of patients absorb too little of the drug for it to effectively prevent strokes, while another segment absorbed too much of it and were at a higher risk for bleeding. The released documents included emails, memos, and internal presentations, according to the Times.

According to the Times, some observers said the documents show that “drug makers and regulators had been too eager to approve such powerful drugs without more careful monitoring.”

About 850,000 patients have been prescribed Pradaxa, and more than 1,000 have died.

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