With the use of oral anticoagulants growing rapidly, the debate rages on about whether these drugs have a net positive effect or carry risks that outweigh the benefits.
Last week, the maker of Xarelto touted the results of a new study showing the drug may reduce the occurrence of major cardiac events. This came on the heels of a consumer safety group warning of increased dangers of internal bleeding from the entire class of blood thinners that also includes Pradaxa and Eliquis.
The novel oral anticoagulant drug (NOAD) class began in 2010 with the launch or Pradaxa, and was followed in 2012 by Xarelto and Eliquis. Each drug claims to be safer and easier to use than warfarin, however, rampant reports of internal bleeding and death have plagued all three.
Promising Heart Data for NOADs
First, the good news: the recent Phase III COMPASS trial conducted by the Data Monitoring Committee measured the effects of Xarelto on heart injuries. Last week, it was reported that the trial results were so positive that the study was stopped early.
According to a press release from Bayer, the study of more than 27,400 patients worldwide compared cardiac event occurrence rates among those given only aspirin, those given only Xarelto, and those given a combination of both.
Early data indicated Xarelto was beneficial at preventing major cardiac events such as heart attacks, stroke and cardiovascular death. This should significantly increase the prescribed uses of the drug, which was already given to millions of patients each year to prevent blood clots.
Growing Internal Bleeding Risks
Now for the troubling news: the independent group Institute for Safe Medication Practices has reported that anticoagulant use is not only growing rapidly, but ranks as one of the most dangerous prescription drug classes on the market.
The ISMP noted that use of oral anticoagulants increased 6.8% by the end of 2015, growing every year since the new class was introduced in 2010.
At the same time, adverse event reports submitted to the FDA for the entire year of 2015 found over 34,000 drug side effects for oral anticoagulants. This included nearly 3,000 deaths and over 9,500 hospitalizations. The most common cause was internal bleeding in the intestines or brain.
And, due to under-reporting, the group estimated the true number of blood thinner side effects was 10 to 100 times higher. Since the average age of anticoagulant patients is 73, they named anticoagulants like Pradaxa, Xarelto and Eliquis the highest risk drugs among older patients.
Dangers and Lawsuits Grow with Anticoagulant Use
The practical implications are that use of oral anticoagulants is growing fast, and will only increase more rapidly with new data showing they may prevent heart injuries. With this comes added risk that patients will suffer serious or fatal internal bleeding injuries.
Already, tens of thousands of families have filed Xarelto, Pradaxa or Eliquis lawsuits after loved ones were hospitalized or killed from internal bleeding. The maker of Pradaxa has paid out over $650 million in damages and now faces a new round of cases.
Trials in the Xarelto litigation are scheduled to begin this spring, with rumors that Bayer/Johnson & Johnson will have to pay out billions to patients to avoid negative publicity.
If you or a loved one suffered internal bleeding while using Eliquis, Pradaxa or Xarelto, it isn’t too late to get legal help or join the litigation. Contact us today to speak directly with a lawyer at no cost, and begin your case.
Casey, T. Rivaroxaban trial stopped early due to positive results in coronary artery disease patients. Cardiovascular Business. (February 9, 2017). Retrieved from www.cardiovascularbusiness.com
ISMP Quarterwatch. Oral Anticoagulant Use and Injuries Increase. (June 29, 2016). Retrieved from www.ismp.org
Last summer, the Department of Justice unveiled the details of an ongoing lawsuit and resulting settlement against industrial giant 3M, claiming the company had furnished defective combat earplugs to millions of U.S. troops serving around the world.