The prescription blood-thinner Pradaxa was first prescribed to prevent blood clots in people with atrial fibrillation. While the anti-clotting action of Pradaxa can treat this condition, it can also lead to potentially fatal bleeding.
Pradaxa was approved in October 2010. It was considered an upgrade from the blood-thinner warfarin because it limited strokes, required less maintenance and was designed to have fewer side effects. 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. In 2011, Boehringer Ingelheim, the German manufacturer of Pradaxa, spent $464 million to promote the drug. In the first quarter of 2012, worldwide sales reached $209 million. The anticoagulant therapy market is estimated to bring in $10 billion a year in the United States alone.
After only two years on the market, Pradaxa had been linked to more than 500 deaths. By 2014, it was being reported that Pradaxa may have been responsible for more than 1,400 deaths. Pradaxa has caused uncontrollable bleeding in thousands of patients. Pradaxa does not have an antidote to stop its anti-clotting action in an emergency. This leaves surgeons with limited options if someone taking Pradaxa develops internal bleeding such as:
- Brain hemorrhaging
- Gastrointestinal bleeding
- Kidney bleeding
- Internal bleeding.
It is a drug manufacturer’s responsibility to perform thorough testing and notify the FDA and the public of the any relevant information that becomes available on a drug’s risks and side effects. In May, 2014, the manufacturer of Pradaxa settled more than 4,000 lawsuits for $650 million. The FDA continues to monitor post-market reports for evidence of inappropriate dosing, use of interacting drugs and other factors that might lead to a bleeding event and will communicate any relevant information on the risk of bleeding and Pradaxa.
If you think you may have been harmed by this drug and would like to speak about it, please give us a call today at 609-641-6200.
As a partner with D'Arcy Johnson Day, Andrew D'Arcy has been involved in some of the nation’s most high-profile cases and investigations. His practice includes serious automobile accidents, medical malpractice, wrongful death and product defect cases. Andrew has been personally responsible for numerous multi-million dollar settlements and verdicts on behalf of his clients. He has been recognized by his peers as an "AV" rated attorney, the highest possible rating given by Martindale-Hubbell publication. Andrew has been named a "Super Lawyer" by New Jersey Monthly magazine each year consistently since 2013.
One Comment
John
It's wild that they approved Pradaxa yet it's causing people so much pain and injury!
It's always best to find a Los Angeles Personal Injury Attorney once stuff like this occur.
Many thanks for the fantastic read!
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