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The US Food and Drug Administration (FDA) has announced a plan to conduct a safety assessment of the blood thinner Pradaxa (dabigatran). The FDA describes the assessment as “a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of dabigatran or warfarin.”
The study will “assess systematically the rates of bleeding and thromboembolic outcomes associated with the use of dabigatran and warfarin for patients with atrial fibrillation using data from the FDA Mini-Sentinel Distributed Database (MSDD).”
According to the FDA, Mini-Sentinel is a part of the FDA sentinel surveillance system that uses electronic healthcare data from nearly 100 million patients.
Pradaxa manufacturer Boehringer Ingelheim issued a statement following the news of the study announcement saying, “[the] fact that FDA requests and receives data on a particular product through Mini-Sentinel does not necessarily mean there is a safety issue with the product.”
Studies done in other countries have showed that individuals using Pradaxa have roughly a 33 percent higher risk for fatal health risks as compared to individuals using the blood thinner warfarin.
If you have used Pradaxa and have experienced any adverse side effects our defective drug attorneys are on the patients’ side. Contact our injury lawyers toll free at (888) 841-9623 to discuss the Pradaxa lawsuit. Our firm offers confidential, no obligation consultations.
Zoll & Kranz, LLC – Pradaxa attorneys
Michelle is a founding partner of Zoll & Kranz, located in Toledo, Ohio. Michelle has been a plaintiff’s lawyer for the entirety of her practice – over 32 years. She devotes the majority of her time to complex consolidated litigation and class action including advocating for people injured by medical devices, prescription medications, or corporate negligence.
This article has been written and reviewed for legal accuracy and clarity by the team of writers and attorneys at Zoll & Kranz, LLC and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced Ohio injury lawyer, Michelle L. Kranz, you can do so here.
Zoll & Kranz, LLC does everything possible to make sure the information in this article is up to date and accurate. If you need specific legal advice about your case, contact us. This article should not be taken as advice from an attorney.
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