Defective Drugs: Xarelto

Have you or a loved one taken Xarelto, the blood thinner that prevents the formation of blood clots? This is just one of the many drugs that was deemed ‘defective’ and went under scrutiny. Every day, Americans are injured by side effects due to dangerous drugs. Since the year 2000, the Food and Drug Administration (FDA) has approved approximately 24 drugs a year, including many that pose health risks and serious long-term side effects. The unfortunate matter is that FDA action can take years, which is something that many patients may not have.

Now that you know a bit about how the FDA works, you may be wondering where Xarelto comes into play with all of this. Xarelto is manufactured by Bayer Healthcare, a name in pharmaceuticals, which you may have heard before. It is a drug used to treat patients who have had blood clots like deep vein thrombosis and pulmonary embolism. It works to prevent them from reoccurring and is used to reduce the risk of blood clot formation and stroke in patients. In 2013 alone, Xarelto generated sales of over $1.3 billion worldwide.

Why Is Xarelto Dangerous?
If you have undergone a spinal tap or receive spinal anesthesia (Epidural), have a genetic spinal defect, have a spinal catheter in place, or a history of spinal surgery, then you should be wary. Xarelto can cause a very serious blood clot around your spinal cord if you have experienced any of these things. It is also something to be aware of if you use other drugs that can affect blood clotting. This type of blood clot can lead to long-term or permanent paralysis. You may also bleed more easily if you have a bleeding disorder that is inherited or caused by disease, hemorrhagic stroke, uncontrolled high blood pressure, stomach or intestinal bleeding/ulcer, or if you take certain medicines such as aspirin, heparin, warfarin, or clopidrogel.

If you are pregnant, you should be wary as well. Xarelto is listed under the FDA as a category C, which is not recommended during pregnancy. It isn’t known whether or not this drug will cause harm to a baby but it is known that the medicine could cause bleeding complications during childbirth. It is also not known whether rivaroxaban passes into breast milk or if it could harm a nursing baby, therefore it should not be taken if you are nursing.

Black Box Warning
Xarelto’s prescribing information includes something that is called a “black box warning.” This is the most serious warning that can be given by the FDA. This warning includes information about the increased risk of blood clot formation after Xarelto was discontinued. These warnings appear on a prescription drug’s label and are designed with an intention to alert prescribers and patients to life-threatening risks.

The FDA received 680 adverse reports in 2013 regarding Xarelto use. In July 2014, there was a lawsuit filed on behalf of a man who experienced uncontrolled brain bleeding after using the drug after only taking it for 10 days. Lawyers for plaintiffs claimed that the company failed to adequately warn patients and withheld information from consumers and the healthcare community about the risks of Xarelto as well as the lack of an antidote.

If you or a loved one has become injured or died due to a defective drug, you should consider speaking to an attorney about your options. Welebir | Tierney will work with you to get you the compensation you deserve and help you get back on your feet during an event of a drug causing you serious problems. Now you can get the compensation you deserve for your suffering.


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