Pradaxa Investigation By FDA Based on Increasing Injury Reports
The U.S. Food and Drug Administration (FDA) announced on January 3, 2014 that it has established a study to evaluate the safety of blood-thinning treatments Pradaxa and warfarin. The Pradaxa investigation will be conducted via the agency’s Mini-Sentinel initiative, which is part of the regulators’ surveillance system. If you or a loved one took Pradaxa and you suffered from complications, contact a Pradaxa lawyer to learn more about your legal rights.
Pradaxa Investigation Continues
Although the bleeding risk of Pradaxa has been of concern to the FDA since the drug’s approval in 2010, clinical reviews have not found the risk of bleeding of Pradaxa to be greater than warfarin. However, Pradaxa continues to top the list for reports of adverse events, and the FDA has decided to launch a Pradaxa investigation to determine the relationship between the medications and the increased risk of bleeding.
The Mini-Sentinel program, which assesses electronic healthcare data to monitor the safety of FDA-regulated medical products, can currently tap a database of over 100 million patients. In an email, drug maker Boehringer Ingelheim stated that simply because the FDA requests and receives data on a product through this initiative does not necessarily mean that the product has safety concerns.
Regulators for the FDA stated that it will conduct a one-time Pradaxa investigation of selected safety outcomes in patients with atrial fibrillation who are new patients of Pradaxa or warfarin and that the objective of the investigation is to assess the rates of bleeding associated with the use of these medications. The agency also noted that while the numbers of intracranial bleeding were lower for Pradaxa than warfarin, Pradaxa had a higher rate of gastrointestinal bleeding than warfarin.
The FDA also asserted that the rising prevalence of risk factors such as heart failure, diabetes and hypertension as well as the aging of the Baby Boomers in the U.S. may be primary cause for concern and that atrial fibrillation may continue to rapidly increase with an estimated 6 to 12 million patients by 2050. Although the document acknowledges that the bleeding rates for Pradaxa and warfarin were similar, the agency still has questions regarding the outcomes of these medications in typical clinical practice populations.
At this point, the Pradaxa investigation is only to encompass the bleeding risks of the medication, and it is not the first time the FDA has turned to Sentinel to evaluate the medication. The FDA reviewed insurance claims in 2012 from an early version of the system and determined that bleeding reports from patients taking Pradaxa were roughly the same as those for warfarin.
Pending Pradaxa Lawsuits
Pradaxa was initially intended to help prevent strokes in patients with atrial fibrillation. Additionally, doctors may prescribe the drug to those undergoing knee or hip replacement procedures to prevent deep vein thrombosis or blood clots from forming and traveling to the heart, brain and lungs.
Although warfarin is not as easy to use as other alternatives, it possesses an advantage that Pradaxa does not have; it has a quick-acting antidote, vitamin K. Although drug makers are working to develop an antidote for Pradaxa, the lack of a medication to reverse the bleeding effects is one complaint in recent Pradaxa lawsuits brought forth by plaintiffs and their Pradaxa lawyers across the country.
According to Pradaxa lawyers, there are currently more than 2,000 Pradaxa lawsuits pending in Illinois in which plaintiffs accuse the drug maker of failing to provide adequate warnings regarding the potentially increased risk of Pradaxa bleeding. The company grossed more than $811 million in sales from Pradaxa in the first six months of 2013, despite the FDA receiving 542 claims of deaths in patients taking Pradaxa. Aside from internal bleeding, plaintiffs have allegedly suffered from heartburn, vomiting, nausea, gastrointestinal ulcers, GERD and abdominal discomfort or pain, according to the Pradaxa lawyers representing them.
Need a Pradaxa Lawyer?
If you or someone you love took Pradaxa and have questions about the Pradaxa investigation or you subsequently suffered from blood clots, strokes or other adverse complications, consider consulting a Pradaxa lawyer to learn more about your legal rights. At the American Injury Attorney Group, we can provide you with a no-obligation consultation, free of charge, to help you to determine if you have a valid case. We will answer your questions to the best of our ability and connect you with an affiliated Pradaxa lawyer who will handle your claim throughout the legal process.