Pradaxa is a blood thinner used to treat blood clots and to prevent strokes or heart attacks in people susceptible to the formation of clots. It is made by German Pharmaceutical company Boehringer Ingelheim, and has been on the market since it was approved by the U.S. Food and Drug Administration (FDA) in 2010. Along with other recent blood thinners, Pradaxa was created to be a safer alternative to warfarin, which has been used as a blood thinner for decades.
Although there are benefits of using Pradaxa and it is in many ways safer than warfarin, there are some serious issues too. These have cost Boehringer Ingelheim a lot of money in settlements and include deaths blamed on the drug, most due to excessive bleeding. If you have been negatively impacted by use of Pradaxa, you could be in a position to start or join lawsuit and seek monetary damages.
Uses for Pradaxa
Pradaxa is the brand name for the generic compound called dabigatran. It is indicated for the treatment of deep vein thrombosis and pulmonary embolism. The latter is a blood clot, often one that forms in the leg, but which can move throughout the body and ultimately cause a stroke or heart attack. Pulmonary embolism is a clot that forms in the lungs, which can also be life-threatening. It is also given to patients who have been treated for these conditions, to prevent a recurrence of a clot.
Dabigatran is also given to people who are at risk of developing blood clots, such as patients who have just had hip surgery or people with atrial fibrillation, a heart condition that can lead to clot formation. In all of these cases, the main reason for prescribing a patient Pradaxa is to prevent death from a stroke or a heart attack.
How it Works Compared to Warfarin
Dabigatran belongs to a class of blood thinner drugs, or anticoagulants, called direct thrombin inhibitors. Thrombin is a protein involved in the clotting process. Dabigatran interferes with it and prevents clots from forming. Before newer blood thinners like Pradaxa came on the market, warfarin was most commonly used to prevent clot formation and it works differently.
Warfarin interferes with a substance called vitamin K, necessary for clot formation. It is effective at preventing clots, but it has serious drawbacks. One is that it interacts with a lot of medications and even foods that contain vitamin K, like leafy greens. Safe dosing of warfarin is difficult so patients using it have to be monitored frequently by a doctor. It can too easily cause excessive and life-threatening bleeding, although there is an antidote that can reverse the effect if given quickly enough.
Studies have shown that Pradaxa may be more effective in preventing clots and in turn preventing heart attacks and strokes than warfarin. It also has fewer drug interactions and does not require the strict monitoring of warfarin use. Unlike some of the other newer blood thinners on the market, like Eliquis, Pradaxa does have an antidote to reverse its effects in the case of excessive bleeding. Boehringer Ingelheim developed the antidote and it was approved by the FDA in 2015.
The most common side effects caused by taking Pradaxa are gastrointestinal: stomach upset, stomach pain, nausea, and heartburn. They should not be severe and should not persist, but if they do, you can tell your doctor and find out if you need to switch to another medication.
More serious side effects are possible with Pradaxa, so if you experience any of these they should be reported right away: bleeding and bruising, bloody urine or stools, vomiting or coughing blood, heavy menstrual bleeding, nosebleeds, bleeding gums, joint pain or swelling, dizziness, weakness, headaches, hives or rash, trouble breathing, chest pains, or swelling in the face, mouth, or throat.
Patients taking Pradaxa are also warned against stopping use of the drug without a doctor’s guidance. Doing so can increase your risk of having a blood clot form. The only reason to suddenly stop taking it is in the case of excessive bleeding. Pradaxa also comes with a warning that any patients going under anesthesia or getting a spinal puncture for any reason should not take the medication. Doing so could lead to a spinal clot that causes permanent paralysis.
One of the most serious possible consequences of taking any blood thinner, including Pradaxa, is excessive bleeding. Because this medication prevents clotting, any bleeding can become out of control and be dangerous or even life threatening. If you take this medication and bleed excessively, you need to seek medical attention immediately.
Newer anticoagulants like Pradaxa have been marketed as safer than warfarin, but Boehringer Ingelheim has come under fire for misrepresenting and withholding important information about the bleeding risks when taking Pradaxa. The company actively marketed Pradaxa as a blood thinner that did not require the careful monitoring of patients to prevent excessive bleeding, as warfarin does. A series of studies published in 2014, though, found that there was a greater risk of dangerous intestinal bleeding in older patients taking Pradaxa as compared to warfarin.
This risk of bleeding was especially dangerous before Boehringer Ingelheim had developed its antidote to Pradaxa. They are accused of knowingly promoting a drug that could cause serious bleeding and hiding evidence of this dangerous side effect without even having an antidote that could reverse it. Hundreds of reports of adverse effects related to excessive bleeding came in before the evidence came to light and the FDA announced the risk.
Another problem that arose with the use of Pradaxa came to light in studies published in 2012. These studies found that the risk of having a heart attack was slightly higher for patients taking Pradaxa than other anticoagulants including warfarin. The studies’ authors concluded that doctors needed to be cautious in prescribing Pradaxa, that the balance of benefits and risks may not be as straightforward as the drug maker had suggested up to that point.
Between 2010 and 2013 individuals who either suffered excessive bleeding or who had lost family members to bleeding while taking Pradaxa, filed thousands of lawsuits and liability claims against Boehringer Ingelheim. By 2014 the company had reached a settlement, but also denied wrongdoing, citing the study that found Pradaxa could cause intestinal bleeding. This study concluded that the drug still had enough benefits to outweigh that risk for many patients. Unfortunately that balance swung the other way for too many people who suffered from bleeding.
The ultimate settlement was for $650 million to cover around 4,000 cases in the U.S. The settlement was not easy to achieve with the FDA stating that Pradaxa still had a good benefit to risk ratio and with the drug company claiming that it is widely known that any anticoagulant comes with a risk of bleeding. The sticking point, though, was that Boehringer Ingelheim prematurely claimed that there was no need to monitor patients taking Pradaxa. This turned out to be untrue for certain patients.
- http://docs.boehringer-ingelheim.com/Prescribing Information/PIs/Pradaxa/Pradaxa.pdf
- http://www.forbes.com/sites/larryhusten/2014/05/28/boehringer-ingelheim-settles-us-pradaxa-litigation-for-650-million/ - 79174ac5268a
- http://content.onlinejacc.org/article.aspx?articleid=1204644 - tab1