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New Evidence Comes to Light as Boehringer Faces 2,000 Pradaxa Lawsuits

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Approved in October 2010, Pradaxa is prescribed to patients with non-valvular atrial fibrillation, to help reduce the risk of stroke. A blood thinner similar to warfarin, Pradaxa was initially marketed as being superior to warfarin because it required no dietary restrictions or blood monitoring.

Within just a year, however, Pradaxa was associated with hundreds of excess bleeding problems, many leading to death. Now, according to a recent report in Reuters, manufacturer Boehringer faces more than 2,000 Pradaxa lawsuits claiming the drug caused severe and fatal bleeding.

Studies Report on Pradaxa Bleeding Risk

Though all blood-thinning medications come with a risk of excess bleeding, Pradaxa seemed to be associated with a higher-than normal amount of cases. In January 2012, the FDA requested changes to the label that would warn of increased risks of bleeding events and of additional risks in patients with renal (kidney) impairments. By the end of the year, however, after the agency finished a review of post-marketing complaints, they stated the bleeding rates associated with Pradaxa didn’t appear to be higher than those associated with warfarin.

Studies, however, continue to question this conclusion. In February, researchers reported in the Journal of the American College of Cardiology Pradaxa increased risk of bleeding more than warfarin. Those taking Pradaxa experienced a higher major bleeding rate (6 percent vs. 1 percent), total bleeding rate (14 percent vs. 6 percent), and blood clot complications (16 percent vs. 6 percent).

Another study published in September 2013 in the New England Journal of Medicine reported that in patients with mechanical heart valves, compared to warfarin, Pradaxa caused a greater risk of blood clots and bleeding complications, including stroke. Researchers concluded it had no benefit and an excess risk for this vulnerable population.

Two other studies published in 2013 showed that Pradaxa increased risk of heart attack more than comparative drugs—anywhere from 38 to 70 percent increased risk.

Court Documents Reveal Manufacturer Considered a Cover-Up

Plaintiffs filing Pradaxa lawsuits against manufacturer Boehringer Ingelheim typically claim that the company failed to provide adequate warnings about the risks associated with their product. In addition to the excess bleeding risks, Pradaxa also has a unique risk not present with warfarin. Whereas the blood-thinning effects of warfarin can be counteracted with injections of vitamin K, Pradaxa has no such readily available antidote, making bleeding events potentially much more serious.

According to the New York Times, recent documents made public in the Illinois Pradaxa MDL revealed that the drug makers were so worried that an internal research paper on the drug may damage sales that some employees pressured the author to revise it, and also suggested it should be scratched completely. Company emails, memos, and internal presentations centered on whether the paper would call into question one of Pradaxa’s main selling points—that it doesn’t require regular blood monitoring. The results of the paper showed that some patients could benefit from such monitoring—but these results no longer appear in the article.

Warfarin has long required regular blood tests to be sure the dosage was working properly in each patient. Depending on the tests, doctors could choose to adjust the dosage to be sure the proper amount of drug—not too much, not too little—remained in the patient’s system. Pradaxa has been marketed as being more convenient, with one-size-fits-all dosages. But many healthcare professionals have questioned this logic when using the drug, noting that certain populations don’t metabolize the drug in the same way as others. This internal study seems to confirm those concerns.