German pharmaceutical company Boehringer Ingelheim is now facing more than 2,000 lawsuits in the United States for its drug Pradaxa, according to a recent FiercePharma article. In the lawsuits, plaintiffs are claiming that this stroke prevention drug (which is a blood thinner) was the cause of severe bleeding in patients, many of whom have died as a result of the bleeding. The plaintiffs are alleging that the drug manufacturer failed to adequately warn patients of the risks associated with Pradaxa. These lawsuits come at a time when the U.S. Food and Drug Administration (FDA) is taking a closer look at the safety of this drug by comparing outcomes in Pradaxa patients with outcomes in warfarin patients. The FiercePharma article covers information that has been reported by Reuters and The New York Times.
According to The New York Times, of the more than 850,000 patients who have been prescribed Pradaxa, more than 1,000 of those patients are reported to have died in fatalities linked to the drug. As reported by Reuters, Boehringer Ingelheim pointed to an FDA to show that the risk of severe bleeding is lower for patients using Pradaxa than it is for patients using warfarin. Pradaxa is one of multiple newer-generation drugs that are attempting to take the place of warfarin, which has been used for decades to prevent strokes in patients who have atrial fibrillation. Atrial fibrillation is a heart-rhythm disorder that affects many elderly patients.
While Pradaxa's and warfarin's rates of serious bleeding are seen as being comparable, physicians are particularly worried about Pradaxa. This is because of the fact that, unlike warfarin, this drug and other similar drugs on the market do not have an antidote (something that can stop excessive bleeding once it starts), according to FiercePharma. Pradaxa's competitors—the other next-generation drugs—include Eliquis (by Bristol-Myers Squibb) and Xarelto (by Bayer and Johnson & Johnson).
The New York Times and FiercePharma reported that a federal judge in Illinois recently released documents showing that Boehringer Ingelheim's marketing managers raised concern over whether new research results on Pradaxa should be publicized. The internal research paper stated that some patients could benefit from having their blood monitored when taking Pradaxa, particularly since certain groups of patients may be more prone to absorbing to little or too much of the drug. Marketing managers and other employees of the company argued that these results could come into conflict with one of the major selling points of Pradaxa, which is that this drug (unlike warfarin) does not require regular blood tests.
When pharmaceutical companies fail to make their drugs reasonably safe for patients, or when they fail to properly warn patients of the health risks associated with their drugs, they must be held accountable for their actions. If anyone in your family has been harmed or killed by Pradaxa, you can turn to our Pradaxa lawyers at Jackson Allen & Williams, LLP for help filing a lawsuit against the company that is at fault. We handle
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