How Strong is Your Pradaxa Case?

By Independent Staff Writer
If your doctor has prescribed the relatively new drug, Pradaxa, as an alternative to Warfarin, you may have been alarmed to hear of the potential issues with Pradaxa. Pradaxa was approved by the FDA in late 2010 after the manufacturer, Boehringer Ingelheim, presented the drug as a much better alternative to Warfarin, which had been used exclusively since the 1950’s as a treatment for the prevention of systemic embolisms and strokes. Pradaxa is used to treat patients with atrial fibrillation and works primarily by thinning the blood of the patient. While Pradaxa did appear to work slightly better than Warfarin, it has been shown to have serious side effects, some of them fatal.

How Does Pradaxa Work?
The primary issue with Pradaxa lies in how it works in the body. While both Pradaxa and Warfarin are used to prevent strokes in patients with atrial fibrillation, Warfarin works through the inhibition of Vitamin K in the body. Vitamin K is a clotting agent, and should Warfarin cause excessive bleeding in a patient, doses of Vitamin K can be administered to slow the bleeding. Pradaxa works by inhibiting an enzyme in the blood known as a thrombin. Thrombins are also responsible for controlling blood clotting, however at this time there is no known reversal agent to Pradaxa and should it cause excessive bleeding physicians have no way of slowing or stopping the bleeding. In the case of excessive bleeding among Pradaxa users they have no choice but to wait 12 to 24 hours until the drug has cleared their system, allowing the blood to clot as it should.

Pradaxa (Dabigatran) and the FDA Safety Review

By Independent Staff Writer 

Although only on the market for a relatively short period of time, Pradaxa, the blood-thinning drug manufactured by Boehringer Ingelheim—has already suffered under the weight of threatened recalls, lawsuits and warnings by the FDA. Pradaxa is the first FDA-approved drug of its type since the drug Warfarin was approved in 1954. Both Warfarin and Pradaxa are commonly prescribed as blood thinners to reduce the risk of stroke in patients with heart rhythm irregularities.

Warfarin was used almost exclusively until November of 2005 when Boehringer Ingelheim sponsored a clinical trial to determine the long-term safety and effectiveness of their “new kid on the block,” Pradaxa. The Pradaxa blood-thinning drug trial concluded in March of 2009 to rave reviews. More than 18,000 patients were enrolled in the trial across 44 countries. Boehringer announced that Pradaxa was able to significantly reduce the risk of stroke when compared to the older established drug, Warfarin, and that it had similar or even reduced risks of causing major bleeding in the body—depending on the dosage.

Pradaxa (Dabigatran) Lawsuits

By Independent Staff Writer

March of 2012 saw the first lawsuits filed against Boehringer Ingelheim, the manufacturer of Pradaxa. This drug was the first of its type to be marketed in over half a century, and Boehringer had high hopes that Pradaxa would knock its only competitor, Warfarin, out of the running in short order. Pradaxa works differently from Warfarin; while both drugs are used to prevent stroke in patients with atrial fibrillation, Warfarin works by inhibiting the production of Vitamin K, a clotting agent in the body. Should there be excessive bleeding in a patient who has taken Warfarin, doses of Vitamin K can be administered to slow the bleeding. Pradaxa, on the other hand, works by inhibiting thrombin, an enzyme in the blood which also controls blood clotting. At this time there is no known antidote to Pradaxa in the event it leads to excessive or uncontrollable bleeding.

What is Atrial Fibrillation?

Atrial fibrillation affects more than two million Americans and is characterized by rapid, uncoordinated contractions in the upper chambers of the heart. Patients with atrial fibrillation are at a much higher risk of developing blood clots, and since the 1950’s doctors have been using Warfarin—which is also known as Coumadin—to help lessen the likelihood of stroke. The FDA approved Pradaxa for use in patients with atrial fibrillation in October of 2010, yet less than a year later reports were coming in regarding serious side effects and even death among Pradaxa users. In December of 2011, in the face of hundreds of adverse reports, the FDA issued a safety warning to patients and physicians, stating they would taking a hard look at the prior Pradaxa studies.

The Dangers of Pradaxa (Dabigatran): Part 1 of 3: Side Effects and Complications

By Independent Staff Writer

The newest drug approved for use in the treatment of heart valve problems or atrial fibrillation among patients with an increased risk of stroke is the drug Pradaxa, manufactured by Boehringer Ingelheim. The drug Boehringer is seeking to replace with its newest arrival is Warfarin—a blood-thinning drug which has been used since the early 1950’s. Boehringer claims that Pradaxa is over 30% better in decreasing the risk of a serious stroke than Warfarin. The FDA initially agreed with Boehringer, granting FDA approval of Pradaxa in October of 2010.

What is Atrial Fibrillation and How Does Pradaxa Help?

Atrial fibrillation affects over two million Americans and involves excessively rapid, uncoordinated contractions of the upper two chambers of the heart. Those with atrial fibrillation are at a much higher risk of developing blood clots which in turn can lead to a disabling stroke should the clot travel to the brain. Pradaxa works by inhibiting thrombin, an enzyme in the blood which controls blood clotting.

The Dangers of Pradaxa (Dabigatran) Part 3 of 3: Serious Vascular Risks

By Independent Staff Writer

Pradaxa, the drug which less than a couple of years ago seemed like a dream come true for the hundreds of thousands of patients who were taking Warfarin or Coumadin has had its initial glow tarnished by the ever-increasing number of reports of serious side effects from use of the drug. Although Warfarin has been used as a stroke inhibitor and for those suffering from atrial fibrillation since the 1950’s, it comes with certain restrictions and its own set of side effects. Those who are on a Warfarin regimen must have regular blood tests taken, and must also be very careful of foods and other prescription drugs they mix with Warfarin.

However, there is a significant difference in the way Warfarin and Pradaxa work in the body, most notably the fact that in the event Warfarin causes excessive bleeding, the effects can be reversed by administering a dose of Vitamin K. When Pradaxa causes excessive bleeding there is no known antidote, leaving the patient vulnerable to literally bleeding to death. Pradaxa is a direct thrombin inhibitor which, in the initial 18,000 person trial, showed great promise in reducing strokes and helping those patients with atrial fibrillation lead a healthier life. The manufacturer of the drug, Boehringer Ingelheim, has been accused of rushing through the initial trial in order to get their drug on the market before other potential rivals, ignoring some potential risks in the process.

The Dangers of Pradaxa (Dabigatran) Part 2 of 3:

By Independent Staff Writer

Some experts feel that the German pharmaceutical company, Boehringer Ingelheim, rushed their new wonder drug, Pradaxa to the market perhaps a bit too quickly in an attempt to beat the competitors to the mark. Pradaxa subsequently became the first drug to rival Warfarin in over half a century. Boehringer announced that Pradaxa was as much as 35% more efficient in decreasing the risk of serious stroke than Warfarin, and in less than a year there were over a million prescriptions issued for the drug to over 400,000 patients hoping to avoid the negative aspects of Warfarin.

How is Pradaxa Used?

Pradaxa is primarily used for patients suffering from atrial fibrillation and to reduce the risks of stroke. Pradaxa also appeared to offer additional advantages over Warfarin in that there was no need for regular blood level monitoring as well as the fact that Pradaxa users didn’t have to be as concerned with mixing Pradaxa with certain foods and other medications as those taking Warfarin. While Vitamin K antagonists, such as Warfarin, are the mainstay of long-term anti-clotting therapy, there certainly exists a need for newer and safer anticoagulants. Pradaxa and other similar drugs currently undergoing trials use thrombin inhibitors as their primary ingredient; unfortunately the side effects of Dabigatran can be serious or even fatal.