Pradaxa FDA Alert

March 28, 2012

In December of 2011, the United States Food and Drug Administration (FDA) released a Safety Announcement regarding recent studies conducted about Pradaxa causing internal bleeding. The Food and Drug Administration (FDA) stated that they were evaluating post-marketing (after sale) reports of severe bleeding events reported in Pradaxa patients. Pradaxa is a popular anticoagulant on the market with billions in sales.

In Pradaxa’s first year on the market, there were more than 250 deaths reportedly caused by Pradaxa related to internal bleeding. Results like that are bound to catch the eye of the Food and Drug Administration (FDA) and sure enough, they are currently reviewing the effects of Pradaxa. The Pradaxa FDA Alert states that Pradaxa is a blood thinning drug meant to lower the risk of stroke in certain patients.

At this time there is currently no Pradaxa FDA recall in effect. The FDA alert states that the bleeding caused by Pradaxa may lead to very severe and even fatal complications in patients. The Food and Drug Administration (FDA) is currently seeking to determine if the Pradaxa internal bleeding reports are occurring at higher rates than normal.

Pradaxa has been submitted into the Food and Drug Administration’s (FDA) Adverse Events Reporting System (AERS) to further investigate what adverse effects may be caused by Pradaxa and to determine if these Pradaxa internal bleeding deaths are occurring at a higher rate than expected.

Pradaxa and Xarelto are both fairly new blood thinning drugs on the market. Previous to their introduction, the most common anticoagulant treatment was warfarin. Pradaxa is preferred by many because it is believed to be easier to dose for patients, requiring fewer blood tests and less examination. However, if Pradaxa or Xarelto are causing significantly more internal bleeding deaths, then it may not be worth the risk according to many health experts.

One reason that warfarin is believed to be safer than Xarelto or Pradaxa is that in the event of warfarin internal bleeding; patients may supplement their intake with Vitamin K to offset much of the internal bleeding danger. For patients taking Pradaxa however, Vitamin K does not have the same negating effects on the internal bleeding.

The manufacturer of Pradaxa, German pharmaceutical company Boehringer Ingelheim, has admitted that roughly 260 cases of fatal internal bleeding have been linked to their drug Pradaxa. They claim that the number of Pradaxa deaths is below the average rate, but the trials are not conclusive. It is impossible to know if the 260 reported Pradaxa deaths are the only Pradaxa deaths which have occurred.

Pradaxa / Xarelto Lawsuit – Speak To a Lawyer

If you or a loved one took Pradaxa or Xarelto and have suffered from internal bleeding or know of someone who has suffered or died from internal bleeding which you believe may be caused by Xarelto or Pradaxa, you may be entitled to financial compensation. Potential Pradaxa and Xarelto internal bleeding lawsuits are currently being reviewed. Please contact our law firm immediately to see if you have a internal bleeding case caused by Xarelto or Pradaxa.