Tamara Burns  |  June 28, 2016

Category: Legal News

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pradaxa-bleeding-problemsPatients who will be undergoing surgery for any reason are told to stop taking blood thinning medications prior to their surgical procedures.

The reason for such a recommendation is to decrease the amount of bleeding that could happen during surgery that is artificially increased from anticoagulant use.

Patients taking Pradaxa (dabigatran) as their blood thinner medication should follow the advice of their doctor with regard to discontinuing Pradaxa and any other medications prior to surgery.

How Long Should Patients Hold Pradaxa Before Surgery?

According to the Boehringer Ingelheim’s website, for most patients, the recommendation is to discontinue Pradaxa use one to two days prior to the surgical procedure. For patients with a higher bleeding risk, Pradaxa should be discontinued for three to five days prior to the procedure.

The manufacturer also recommends extending the amount of time to discontinue Pradaxa before surgery if any of the following pertained to the patient’s situation: patients undergoing major surgery, spinal puncture, spinal epidural catheter or port.

For some patients, however, surgery is done on an immediate basis and is not planned ahead of time. In those instances where there is an increased risk of hemorrhaging and internal bleeding, the bleeding risk should be weighed against the urgent nature of the surgical intervention.

In these cases, the manufacturer recommends having the reversal agent Praxbind available in cases of emergency surgery to counteract the blood thinning effects of Pradaxa.

In patients who discontinue Pradaxa prior to surgery, there is an increased risk of suffering from blood clots at that time. Some patients may be prescribed an alternate anticoagulant to use in its place prior to the surgical procedure.

Pradaxa Side Effects

Pradaxa is one of several new generation oral anticoagulant medications that has come on the market within the last several years.

It is used to prevent blood clots and stroke in patients who have atrial fibrillation, an abnormal heart rhythm. Pradaxa works by blocking the body’s natural clotting mechanism, allowing blood to flow more freely through blood vessels and organs.

Pradaxa and its new cohorts Eliquis and Xarelto have been the only new anticoagulant medications to have been developed and widely used since warfarin (Coumadin) 60 years ago. Patients and physicians were excited to see that these newer drugs needed less frequent monitoring and required no dietary restrictions.

However, what they didn’t seem to plan for upon releasing these drugs was the necessity of having an antidote or reversal agent to stop the excess bleeding when it was needed.

Patients taking Pradaxa and the other new generation oral anticoagulants could develop internal bleeding as a side effect of the medication. This happened with warfarin as well, and is a known side effect of anticoagulant drugs in general.

However, with warfarin there was an antidote. Fresh frozen plasma and intravenous vitamin K were used to reverse clotting in patients who were hemorrhaging.

No such antidotes were released at the time the new drugs entered the market, leading to many reports of severe complications due to internal bleeding and even reports of death.

Five years after Pradaxa’s release onto the market, Praxbind, a Pradaxa antidote, was developed and approved. This reversal agent can help stop the anticoagulant’s effects,  however Praxbind only works for patients taking Pradaxa, and cannot be used as an antidote for Eliquis or Xarelto.

Pradaxa Side Effects Lawsuits

Many patients were affected by Pradaxa side effects during the first five years that Pradaxa was on the market without a corresponding reversal agent.

A number of these patients and families went on to file lawsuits against manufacturer Boehringer Ingelheim saying that it did not warn patients adequately of the severe internal bleeding and hemorrhaging side effects that the drug was responsible for.

In 2014, the manufacturer had more than 4,000 lawsuits against it, and without admitting fault, settled those lawsuits for more than $650 million. Many more lawsuits have been filed since that time and are currently pending in the courts.

If you or a loved one has suffered severe Pradaxa side effects, you may be eligible for legal compensation.

In general, Pradaxa lawsuits are filed individually by each plaintiff and are not class actions.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The Pradaxa attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or Pradaxa class action lawsuit is best for you. Hurry — statutes of limitations may apply.

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