A University of Illinois study suggested the FDA data may be flawed, and Pradaxa bleeding risks may be higher than expected.
New York, NY (PRWEB) July 08, 2013
The prescription drug resource center DrugNews.net is announcing updated news for patients taking the blood thinner Pradaxa. The maker of the drug, Boehringer Ingelheim, is seeking to market it for more uses despite recent health warnings and growing injury claims*.
DrugNews was created to improve the safety of patients taking popular prescription drugs like Pradaxa by sharing the latest warnings, recalls, studies and legal news. Visitors to the site can see if others are experiencing similar side effects and decide if they need legal advice.
Pradaxa is a blood thinner approved by the FDA in 2010 as a stroke preventative for patients with atrial fibrillation. Experts disagree, however, about its risks for internal bleeding. The FDA has advised Pradaxa is no more dangerous than traditional blood thinner warfarin**.
Others, like the Institute for Safe Medication Practices, have warned that patients may be 5 times as likely to die from bleeding with Pradaxa than that from warfarin***.
A University of Illinois study suggested the FDA data may be flawed, and Pradaxa bleeding risks may be higher than expected****. Also, a recent Danish study concluded patients’ risks of internal bleeding may be heightened when switching from other blood thinners to Pradaxa*****.
A growing number of patients have filed a Pradaxa lawsuit alleging internal bleeding, with over 1,000 cases now being consolidated to a special federal court in Illinois. The case is formally known as MDL No. 2385, IN RE: Pradaxa Product Liability Litigation, Southern District of Illinois.
Now, DrugNews has learned that the maker of Pradaxa, Boehringer Ingelheim, hopes to expand its use, as they petitioned European health regulators last month to market the drug as a preventative for blood clots in all patients, not just those with atrial fibrillation*.
Anyone affected by internal bleeding after taking Pradaxa is encouraged to visit DrugNews.net or speak with a lawyer about their legal options. However, due to the specialized nature of federal drug injury cases, DrugNews only recommends lawyers who have already handled Pradaxa lawsuits.
*FiercePharma, 6/26/13; fiercepharma.com/story/xarelto-pradaxa-eye-big-growth-expanding-anticoagulant-market/2013-06-26?utm_medium=nl&utm_source=internal
**FDA, 11/2/12; http://www.fda.gov/Drugs/DrugSafety/ucm326580.htm
***Institute for Safe Medication Practices, 1/9/13; ismp.org/quarterwatch/pdfs/2012Q2.pdf
****New England Journal of Medicine, 4/4/13; nejm.org/doi/full/10.1056/NEJMp1302834
*****British Medical Journal, 5/3/13; bmjopen.bmj.com/content/3/5/e002758.long