When Pradaxa (dabigatran) hit the market in October 2010, you would think it was the next best thing to sliced bread.
For more than 50 years, Coumadin (warfarin) was the standard treatment when there were early indications that someone could suffer a stroke or heart attack. A diagnosis of non-valvular atrial fibrillation, or an irregular heartbeat, almost always earned a prescription for Coumadin as did a diagnosis of thrombosis or thromboembolism, blood clots in blood vessels that can migrate elsewhere.
Warfarin was actually marketed as a successful rat poison in 1948 after it was noted that the rats would bleed out after ingesting it.
Derived from spoiled sweet clover, Coumadin is present in many plants and as far back as the 1920’s it was noted that many cows died after eating moldy sweet clover. Scientists at the Wisconsin Alumni Research Foundation (WARF) helped turn the plant-based drug into a popular therapeutic anticoagulant and are responsible for the name, warfarin.
In a high profile case, President Dwight Eisenhower was prescribed warfarin after he suffered a heart attack in 1955.
In humans, Coumadin has been the standard treatment for non-valvular atrial fibrillation since 1954. However, there was a drawback. Patients would have to have their blood monitored regularly to make sure their levels were appropriate so they too did not bleed out and die. This took some maintenance and for some it was a mild hassle. For others, it was an inconvenience to the point of being impractical.
Then Pradaxa entered the market in 2010. Manufactured by Boehringer Ingelheim, the main sales pitch for the new anticoagulant was that you didn’t need to monitor your blood.
That’s because there is one main difference between the drugs that never made its way into the glossy brochures that pharmaceutical sales representatives drop off at doctor’s offices.
Unlike Coumadin, Pradaxa does not have an antidote. In a bleeding situation, a patient on Coumadin could be injected with vitamin K causing their blood to coagulate. With Pradaxa, vitamin K is ineffective. Patients taking Pradaxa also report gastrointestinal (GI) upset, particularly those patients over the age of 75.
Boehringer Ingelheim confirmed 260 fatal bleed outs between March 2008 and October 2011 among patients taking Pradaxa. In 2011 alone, there were close to 3,000 reports linking uncontrolled bleeding to Pradaxa use.
One has to wonder why the Society did not recognize the uncontrolled bleeding potential of Pradaxa, which is the subject now of multidistrict litigation (MDL), consolidated by a judicial panel on August 8.
And just last week, doctors from American University in Lebanon urged doctors to use caution in prescribing Pradaxa because of numerous reports of complications including internal bleeding and kidney failure.
Could it be that Pradaxa costs patients more than ten times the amount of a warfarin regimen?
About 75,000 doctors are members of the European Society of Cardiology, so this recommendation has a lot of potential value to the makers of Pradaxa.
Atrial fibrillation affects an average of 2 percent of the population, with most users falling between the ages of 75 to 85. An irregular heartbeat is associated with a fivefold increased risk of stroke and threefold higher risk of heart problems, according to the authors of the guideline and endorsement from St. George’s University of London.
The FDA meanwhile has the drug on its radar and is trying to determine whether reports of Pradaxa bleeding are occurring more often than suggested by the large clinical trial conducted by the drugmaker.