ICBioethics Blog 

Pradaxa Lawsuits Emerging

Written by: Barbara Postol

Many people are diagnosed with a heart condition known as atrial fibrillation.  There is a risk of stroke from this condition as pooling blood could clot and travel to the brain. Therefore, warfarin has historically been prescribed to patients who have atrial fibrillation, to stave off these clots. Warfarin has been around for over 50 years and certainly has risks of its own, but has been the drug of choice for decades for many conditions associated with blood clots. All drugs have risks and benefits and patients are advised of these risks by their prescriber. People who take warfarin have to get regular blood work to monitor their INR. -If it is too high or if it is too low, medication adjustments must be made. This is painful and inconvenient for many patients since this requires frequent needle sticks and extra visits to have blood drawn.

In 2010 a new alternative drug came out on the market called Pradaxa. Pradaxa doesn’t require all of the blood testing like warfarin, which if you have seen the television commercials, seems to be its best selling point. This seems like a great idea and saves people who need a blood thinner a lot of hassle without all of the monitoring, but there are some problems beginning to surface. If your blood is too thin, you can die from excessive bleeding. This is the case for both drugs, but the difference is that there is an antidote for bleeding if you take warfarin. There is not for Pradaxa. Pradaxa has been linked to kidney and liver problems and possibly heart attacks too. It had the most reported deaths in 2011 to the FDA. Because of these problems, lawsuits against the manufacturer have been building and attorneys suggest there will be many more to come, in fact potentially the next big blockbuster lawsuit against a drug.

This raises many ethical questions in the research and development, publishing, profit and more of medications. How does this happen? How do potentially harmful drugs get on the market and why? These are complex questions with no easy answers and raise many ethical red flags in the area of pharmaceutical research and development.

Mitch GennusoComment