Boehringer Ingelheim is putting forth the best face it can on Pradaxa, the blood-thinner that’s been on the market just 18 months and already associated with a host of complications and deaths. The company recently posted new clinical data on 18,113 patients that compared Pradaxa to its competitor, warfarin (Coumadin) and found lower rates among Pradaxa users of fatal and traumatic intracranial hemorrhage, one of the most serious complications of Pradaxa.
This good news is likely to be confusing to patients and their doctors who are paying attention.
A recent study in the Archives of Internal Medicine warned that the anticoagulant is associated with an increased risk of heart attack and excess bleeding.
The same report showed Pradaxa users experienced gastrointestinal bleeding, excess dyspepsia, myocardial infarction and a potential for drug accumulation in patients with kidney and liver dysfunction.
In the second quarter of 2011, the FDA’s Adverse Event Reporting System collected 3,000 reports on Pradaxa earning it the Number 5 spot among the Top Ten Q2 drugs with the most adverse events including 201 deaths, 32 disabilities and 1,002 hospitalizations.
Studies have a shown a 33 percent increase in the risk of having a heart attack among patients taking Pradaxa when compared to warfarin (Coumadin). This is notable because unlike Coumadin, there is no drug that will reverse the anticoagulant properties of Pradaxa and medical personnel are helpless if a hemorrhage begins, especially in the elderly.
Apparently the good news about Pradaxa is winning out over the frightening reports because German drugmaker, Boehringer Ingelheim, is enjoying a strong year largely riding on a wave of Pradaxa sales in the U.S. The family-owned company (run by a scientist, not salesman or marketers) just released news that sales of Pradaxa are predicted to reach $832 million, in its first year on the market (FDA approved October 2010) and more than $1 billion between March 2011 and February 2012, pumping it to the current blockbuster status.
Most of those sales came from the U.S. where Pradaxa became the first drug approved in 50 years for the prevention of strokes in patients experiencing atrial fibrillation.
So what is a patient to do?
The Mass Tort attorneys at Searcy Denney continue to hear the stories from patients who were injured after taking Pradaxa (dabigatran). According to the FDA you should continue taking your medication even as these reports come into the agency concerning complications which may include:
Bleeding, pink or brown urine, red or black tarry stools
Unusual bruising, vomiting blood, gum bleeding
Swelling of the feet, hands or arms
Difficulty breathing, hives, joint pain
It’s important not just to check with your medical professional if you experience any change in your health, but also to report to the FDA’s MedWatch Adverse Event Reporting program. Call 1-800-332-1088 or report online at the FDA Medwatch website.