Something you might want to know about one of the most popular medications on our pharmacy shelves:
More complaints have been registered with the Food and Drug Administration about Pradaxa, a hugely popular blood thinner, than any other drug in the United States.
Even more serious is the fact that over 1,000 patient deaths and thousands of other life-threatening medical conditions have been attributed to the use of Pradaxa.
These statistics come from FDA files, which also show the huge number of patients being treated with Pradaxa: From approval in October 2010 through August 2012, a total of approximately 3.7 million Pradaxa prescriptions were dispensed, and approximately 725,000 patients received a dispensed prescription for Pradaxa from U.S. outpatient retail pharmacies
Most of the public is unaware of the dangerous side effects of Pradaxa but the media has been of late increasing its reporting about these serious bleeding problems.
Detroit television station WXYZ and a sister station in Cleveland recently ran an investigative piece which included the following information about Pradaxa:
“Since it was approved by the FDA in 2010, Pradaxa has been blamed for 1,158 U.S. deaths and 12,494 serious injuries, according to Tom Moore, the senior scientist for drug safety and policy at the Institute for Safe Medication Practices. The ISMP is a non-profit organization that monitors FDA reports.
“The drug is used to treat atrial fibrillation, a heart condition that significantly increases the risk of stroke. ‘We’ve found that this drug had a potential benefit in preventing stroke, but it also had extremely high risk of bleeding as do some other anti-coagulants,’” said Moore.
The station also profiled the plight of a Detroit man who has filed a Pradaxa bleeding lawsuit and told the station “I started hemorrhaging from my teeth, from my nose, and from my stool.”
The report said the man is a retired Detroit firefighter who said he was on Pradaxa for more than eight months when he got violent headaches followed by bleeding.
Blood test results showed he needed to go the emergency room and he ended up getting a life-saving blood transfusion and immediately stopped taking Pradaxa, according to the report. He blames his injuries on the blood thinner.
The retired firefighter is now one of over 2,000 former Pradaxa users who have filed lawsuits in federal court against the medication’s manufacturer, German company Boehringer Ingelheim.
The lawsuits claim that the company is liable for damages and should pay the victims — and those who lost loved ones to fatal bleeding incidents — for allegedly knowing about life-threatening bleeding side effects but failing to issue warnings to patients about these dangers.
Recent court documents in this litigation reveal that Boehringer Ingelheim officials knew that over 1,400 patients had died from serious internal bleeding side effects caused by the medication before they won FDA approval to sell it and withheld that information from government regulators.
That shocking information recently came to light from unsealed court documents in a multi-district federal court litigation involving these thousands of lawsuits filed by Pradaxa patients and loved ones of patients who died of these side effects.