Pradaxa (dabigatran) is a relatively new blood thinning medication that is commonly prescribed to prevent stroke in people that have arterial fibrillation (a-fib) that is not associated with a heart valve leak. Pradaxa first became available to the American public in October 2010. It was previously approved for use in Europe in 2008.
What is Pradaxa?
At first, Pradaxa was seen as having better results that Warafin, the most commonly used blood thinner on the market. Initial testing of the product seemed to show that there was low incidence of side effects when used.
However, less than six months after the medication went into full sales to the public, reports began to surface of bleeding issues related to the use of the product. By December of 2011, a full investigation was underway by the FDA for “serious bleeding events” related to the medication and would start a flood of Pradaxa lawsuit filings by the public.
Pradaxa has been associated with the following negative side effects:
• Spontaneous internal bleeding
• Gastrointestinal bleeding
• Excessive bruising
• Bleeding from the brain
• Renal failure
These adverse effects are more common in patients over 75 years of age. Sadly, this group of people is also in the largest percentage of people who use this medication.
The FDA has stated that Pradaxa, in the first year of its availability to the public, had more reports of problems than any other medication in history. These events included:
• 2367 hemorrhaging events
• 644 Strokes attributed to the medication itself
• 542 deaths
• 291 cases of acute renal failure
• 200 cerebral bleeding events
It should also be taken into account that many doctors fail to report adverse effects of a medication to the FDA.
Additionally, it was discovered that medications and techniques used to stop bleeding events in patients that took other blood thinning medications had absolutely no effect on Pradaxa. Once any type of bleeding event starts on patients taking Pradaxa, it cannot be stopped. This inability to stop any reaction to the medication is what is leading to such high incidence of death and other injuries.
Talking To Your Doctor
If you are being treated for arterial fibrillation and your doctor recommends Pradaxa, it is in your best interest to request more information prior to beginning this type of medication regiment. Discuss with your doctor if the side effects of this medication outweigh the benefits, and ask if there are alternative medications that may be more beneficial to your condition.
Legal Issues and Pradaxa
In August 2012, a U.S. Judicial Panel of Multidistrict Litigation (MDL) was formed to handle the amount of cases being filed against the makers of Pradaxa. Recently, the court announced that an initial trial date was set for August 2014. This court date surprised many since it was less than two years from the establishment of the MDL. In most cases, a trial date can take five or more years before it is heard by the judge.
Many people will need some medication at one point in their lives. Always talk to your doctor regarding the medication, possible side effects and interactions with any other of your prescriptions. It is also important to do your own research so you can be the educated patient and consumer.
Nadine Swayne, a freelance writer on business and legal topics contributes this article in the interest of patient health. Exposure to health damages or death from a prescription medicine can be devastating but, with an experienced and empathetic attorney from the firm of Doyle Raizner LLP, they will help you handle your Pradaxa lawsuit to ensure your family and loved one gets the proper compensation to begin the healing process.
Photo Credit: Erich Ferdinand (CC BY 2.0)