The FDA approved Xarelto, an anticoagulant, in 2011. At first, doctors prescribed the drug only to prevent certain blood clots known as Deep-Vein Thrombosis (DVT) from forming in certain post-surgical patients. Xarelto uses subsequently expanded to help decrease the risk of strokes in patients suffering from atrial fibrillation, and to treat deep vein thrombosis. When Janssen Pharmaceuticals and Bayer introduced Xarelto to the market, there were few, if any, alternatives to warfarin, the anticoagulant drug used for decades to reduce the risk of stroke and to treat other disorders. While warfarin does its job well, taking it requires blood testing and other inconveniences. Xarelto has been aggressively marketed as “easier” than warfarin and is, consequently, used by millions of people across the globe. Recently, patients have filed lawsuits against Bayer and Janssen, claiming that Xarelto has dangerous side effects. If you think you might have a claim because of injuries you sustained while taking Xarelto, our Birmingham, Alabama attorneys at Farris Riley & Pitt are here to assist you. We have plenty of experience with large pharmaceutical companies and will work hard to get you the compensation you deserve.
Like most medications, Xarelto may cause unwanted side effects. Many of them are directly related to the nature of blood thinners. After all, anti-coagulants are designed to make your blood flow more easily by directly effecting clotting proteins in the blood. Some specific side effects patients may experience are:
- Unusual or unexpected bleeding
- Prolonged bleeding
- Brown, red, or pink urine
- Red or black (tarry) stools
- Headaches or dizziness
- Unusual or easy bruising
- Unusual swelling
- Prolonged bleeding from the gums
- Abnormally lengthy or heavy menstrual flow
- Persistent, frequent nosebleeds
- Vomiting blood or something that resembles coffee grinds
- Coughing blood
- Trouble swallowing
- Allergic reaction
- Liver failure
This list reflects some of the side effects that patients have reported while taking Xarelto. At Farris Riley & Pitt, our Birmingham Alabama attorneys will work to help you if you are suffering from any or all of these dangerous side effects. You may be entitled to financial compensation for any physical or emotional suffering you are facing.
Xarelto has no Antidote
In addition to the possibility of the side effects, taking Xarelto comes with an even greater danger that all users should know about:
If you experience a sudden bleeding event, caused by, or while taking, Xarelto, there is no way to stop the bleeding. In other words, there is no known treatment to reverse the anti-coagulant effects of the drug. Medical professionals must wait until the medicine metabolizes out of the body.
If you find yourself in an emergency bleeding situation, there may not be time to wait.
Warfarin, the blood thinner that Xarelto was marketed to compete with, on the other hand, has a widely known and effective reversal agent. A simple dose of vitamin K, allows the blood to clot normally again. Some patients claim that it was irresponsible of Janssen and Bayer to market Xarelto knowing that there was no antidote. Initially, there was not even a warning about this on Xarelto’s label. The FDA eventually demanded that Bayer notify patients about this danger.
Xarelto is High-Risk Treatment
There are at times valid medical reasons why doctors prescribe and patients take blood thinners. But it is important to understand that they come with significant risks. The Institute for Safe Medication Practices (ISMP) is an independent health nonprofit group monitors FDA MedWatch reports. The ISMP calls anticoagulant drugs, such as Xarelto, “a high-risk treatment that causes bleeding in approximately 15 percent of patients with atrial fibrillation exposed for a year.” Be sure to keep in mind that if you are on Xarelto, as opposed to warfarin, there is no known way to stop the bleeding.
The FDA has a system that compiles adverse event, and medication error reports. These reports come from healthcare professionals and consumers. The complaints are sometimes made directly to the products’ manufacturer and, if this is the case, regulations require that the manufacturer share the information with the FDA. The FDA reported that in 2012, they received hundreds of adverse effect reports from Xarelto patients. In the first three months of 2013, the FDA system received over well over 600 adverse reports related to Xarelto.
The ISMP suggested that the increased reports were the result of more prescriptions of Xarelto being written. The ISMP clearly stressed, however that given the bleeding risks associated with these drugs, the safety of Xarelto and other anti-coagulant drugs, is still a significant source of concern. Despite this concern, in recent years, Bayer and Janssen have asked the FDA to approve Xarelto for additional uses such as preventing heart attacks and strokes in patients with ACS (acute coronary syndrome). The FDA has refused to issue approval. Reuters reported that the FDA determined that the benefit of Xarelto for these patients did not outweigh the increased risks.
If you or a beloved family member suffer from an injury caused by Xarelto, our attorneys are here for you. Farris Riley & Pitt has expert pharmaceutical attorneys who understand the pain you are enduring and will work tirelessly to get you any financial compensation you deserve.