Health & Medicine
German Drug Manufacturer Agrees to $650 Million Settlement for Blood Thinner Medication
Thomas Carannante
First Posted: May 28, 2014 11:45 AM EDT
The Boehringer Ingelheim group is headquartered in Ingelheim, Germany and is one of the world's 20 leading pharmaceutical companies. On Wednesday, the German drugmaker announced a settlement with the U.S. regarding its drug Pradaxa.
Pradaxa is a prescription blood thinner that lowers the chance of blood clots forming in your body and is typically prescribed to patients who have medical conditions such as atrial fibrillation, deep vein thrombosis, and/or pulmonary embolism. The German company has agreed to a $650 million settlement to address nearly 4,000 claims that cited severe and fatal bleeding in patients.
Since its introduction to the United States and approval by the Food and Drug Administration in October of 2010, Pradaxa has been prescribed to over 850,000 patients. Those who filed claims said that Boehringer Ingelheim did not issue sufficient warnings of the risks associated with the blood thinner drug.
"We continue to stand resolutely behind Pradaxa® and believed from the outset that the plaintiffs' claims lacked any merit. Notwithstanding our strong belief that we would prevail in these lawsuits, this settlement allows our company to avoid the distraction and uncertainty of protracted litigation over years and years," said Andreas Neumann, Head of the Legal Department and General Counsel for Boehringer Ingelheim worldwide, in this news release.
The settlement amount isn't too costly for the company, and those who filed the claims are likely to be satisfied with it. In 2013, Boehringer raked in $1.63 billion in annual sales for Pradaxa alone, so the $650 million is a win for both sides. Although these claims are very well warranted, Pradaxa has been on the market for longer than six years and has been approved in over 100 countries. Perhaps these countries should run some more clinical trials with the drug to ensure it's being prescribed to the right patients.
Pradaxa was the first widely approved drug in a new generation of direct oral anticoagulants, which work to prevent the coagulations, or clotting, of blood. Without the availability of Pradaxa, many people would be at a higher risk for stroke, but an FDA study of 134,000 Medicare patients found that the drug also drastically increases one's risk of gastrointestinal bleeding. Nonetheless, the drug is likely to now be prescribed more carefully following the news of this settlement.
See Now:
NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone
©2024 ScienceWorldReport.com All rights reserved. Do not reproduce without permission. The window to the world of science news.
More on SCIENCEwr
First Posted: May 28, 2014 11:45 AM EDT
The Boehringer Ingelheim group is headquartered in Ingelheim, Germany and is one of the world's 20 leading pharmaceutical companies. On Wednesday, the German drugmaker announced a settlement with the U.S. regarding its drug Pradaxa.
Pradaxa is a prescription blood thinner that lowers the chance of blood clots forming in your body and is typically prescribed to patients who have medical conditions such as atrial fibrillation, deep vein thrombosis, and/or pulmonary embolism. The German company has agreed to a $650 million settlement to address nearly 4,000 claims that cited severe and fatal bleeding in patients.
Since its introduction to the United States and approval by the Food and Drug Administration in October of 2010, Pradaxa has been prescribed to over 850,000 patients. Those who filed claims said that Boehringer Ingelheim did not issue sufficient warnings of the risks associated with the blood thinner drug.
"We continue to stand resolutely behind Pradaxa® and believed from the outset that the plaintiffs' claims lacked any merit. Notwithstanding our strong belief that we would prevail in these lawsuits, this settlement allows our company to avoid the distraction and uncertainty of protracted litigation over years and years," said Andreas Neumann, Head of the Legal Department and General Counsel for Boehringer Ingelheim worldwide, in this news release.
The settlement amount isn't too costly for the company, and those who filed the claims are likely to be satisfied with it. In 2013, Boehringer raked in $1.63 billion in annual sales for Pradaxa alone, so the $650 million is a win for both sides. Although these claims are very well warranted, Pradaxa has been on the market for longer than six years and has been approved in over 100 countries. Perhaps these countries should run some more clinical trials with the drug to ensure it's being prescribed to the right patients.
Pradaxa was the first widely approved drug in a new generation of direct oral anticoagulants, which work to prevent the coagulations, or clotting, of blood. Without the availability of Pradaxa, many people would be at a higher risk for stroke, but an FDA study of 134,000 Medicare patients found that the drug also drastically increases one's risk of gastrointestinal bleeding. Nonetheless, the drug is likely to now be prescribed more carefully following the news of this settlement.
See Now: NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone