Xarelto is one of the members of the latest generation of blood thinners, also known as anticoagulants. These are drugs that are designed to prevent and sometimes treat the formation of blood clots. They are newer and are supposed to be safer and more effective than the types of blood thinners that have been used for decades, like warfarin.
Bayer developed Xarelto, and like other newer blood thinners, it has no antidote. This makes it very risky for anyone who starts to bleed excessively while taking it. In addition to this possibility, there are several other potential Xarelto side effects that call into question whether it is worth the risks or if it is any better than older blood thinners. Bayer and Janssen Pharmaceuticals, the American company that markets Xarelto, have been called out for misleading advertising and leaving out trial data that may have indicated more of the drug’s risks for users.
Xarelto as a Blood Thinner
The generic name for Xarelto is rivaroxaban. It was developed and tested by Bayer, the German company. Bayer partnered with Janssen, a division of Johnson & Johnson to market Xarelto to U.S. consumers and medical professionals. The main use for Xarelto is to prevent the formation of blood clots in patients who are at risk for developing them. The U.S. Food and Drug Administration (FDA) approved it in 2011 specifically for patients undergoing knee and hip replacement surgeries and those with atrial fibrillation.
Each of these types of patients is at risk for the development of a blood clot, or deep vein thrombosis. This is something that may occur in blood vessels of the legs, but a clot can easily move from there to the heart, brain, or lungs. When that happens, it puts a person at risk of sudden death. If a clot does form in a patient, Xarelto is approved to be used to treat it, to break up the clot.
Xarelto is one of several newer blood thinners that have come out over the last decade. Drug companies have worked hard to create replacements for warfarin and heparin. These older drugs have to be carefully dosed based on individual patients and then those patients must be monitored closely by doctors to prevent dangerous bleeding, the most significant side effect of any blood thinner. Janssen has marketed Xarelto as being more convenient and safer. It has stated that patients do not need to be so carefully monitored and that bleeding is less of a risk.
By far the most common side effect of Xarelto is bleeding. Because the drug works to shut down the coagulation pathway, bleeding while on this drug can quickly become dangerous, out of control, and deadly. Furthermore, it is very hard to stop bleeding because there is no antidote for Xarelto. Warfarin, by contrast, can be reversed by dosing a patient with vitamin K.
The type of bleeding that was seen in patients during clinical trials with Xarelto included brain hemorrhages and gastrointestinal bleeding. These can both be fatal depending on the extent of the bleeding. Signs of potentially dangerous bleeding while on Xarelto include nose bleeds, blood in the urine, bleeding gums, blood in the stool, vaginal or heavy menstrual bleeding, coughing blood, vomiting blood, or headaches with feelings of dizziness and weakness.
In addition to being potentially fatal, excessive bleeding can cause other complications and side effects. These may include poor liver function, tingling or numb muscles, headaches, dizziness, weakness in the legs, bowel or bladder dysfunction, back pain, low platelet levels, and loss of control of muscle movements.
Another potential Xarelto side effect is an increase in the rate of serious infections in patients undergoing hip and knee surgeries. Studies recently published found that there were more infections serious enough to need hospitalization in patients using Xarelto as compared to other blood thinners. These patients experienced more leakage from their surgical wounds along with infections, sometimes deep in the joints. The risk may be as much as four times greater than the risk of infection for patients using warfarin or heparin.
Black Box Warning and Side Effects
The package insert for Xarelto includes black box warnings for two potential side effects that are not common, but serious. One refers to the possibility that a patient who discontinues the drug without a doctor’s direction faces the risk of forming a life-threatening blood clot. Patients are not supposed to stop using Xarelto unless a doctor has directed discontinuation.
The second black box warning refers to patients who have to undergo any type of spinal procedure that includes a spinal puncture. A spinal injection or an epidural, for instance, while on Xarelto, has the potential to cause a patient to become paralyzed. Doctors and patients are encouraged to weigh risks and benefits carefully before combining Xarelto and a spinal procedure.
What Bayer and Janssen Knew about Side Effects
The drug companies responsible for Xarelto have come under fire for unethical, and possibly illegal, practices regarding the marketing and safety information for the drug. One problem is that a clinical trial, called the ROCKET AF, may have been reported with missing data. A reviewer of the trial asked for data and was not given everything. That reviewer also found that the trial used a device for blood measurements that was known to be faulty. Both of these things call into question the results of the entire study.
Another issue is that Janssen has been accused of unethical marketing of Xarelto. The company has aggressively promoted it and has claimed that it is safer and more effective than warfarin. Those who were harmed by the drug feel the company downplayed the risks and made them feel as if Xarelto were safe and low-risk. With the missing data, the poor trial practices, and aggressive marketing, many people are concerned that Janssen and Bayer may be making false claims about Xarelto being safer and more effective than warfarin.
Thousands of cases against Xarelto are pending in courts, most over excessive bleeding. Patients who nearly died because of bleeding, and the loved ones of those who did, feel wronged. They feel they were not warned adequately of the risks and that Janssen and Bayer withheld data and used misleading advertising to promote the drug and get more sales. These practices, they say, put patients in harm’s way. If you were hurt by Xarelto side effects, or you lost a loved one, you may want to file lawsuit or join current suits. Let a lawyer determine what your next step should be in your search for justice and compensation.