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.  

The Dangers of Pradaxa (Dabigatran) Part 2 of 3: Serious Cerebral and Cardiovascular Risks

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.

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.

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.

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. 

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.