Doctors prescribe Bayer’s billion-dollar blood thinner Xarelto to prevent blood clots and protect people from strokes. But the drug may also cause irreversible internal bleeding that can lead to hospitalization and death. Lawsuits filed against Bayer claim the company did not warn the public and want the drug removed from the market.
Did you or a loved one have uncontrolled bleeding after taking Xarelto?
What is Xarelto?
Xarelto (rivaroxaban) is one of the newest anticoagulants – more commonly known as blood thinners. The drug is an oral medication developed by Bayer and Johnson & Johnson’s New Jersey-based unit, Janssen Pharmaceuticals. Blood thinners prevent dangerous blood clots that can obstruct the blood flow to the vital organs. Unlike older anticoagulants that require doctors to prescribe specific doses for each individual, Xarelto belongs to a new type of oral anticoagulant that is prescribed in one uniform dose.
The Food and Drug Administration (FDA) approved Xarelto for use in patients who have had knee or hip replacement surgery to reduce the risk of blood clots, reducing the risk of stroke in people with AF. Following a fast-track regulatory review, the FDA approved the drug for general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Xarelto and Other Anticoagulants
Another better-known oral anticoagulant is the drug Pradaxa (dabigatran etexilate), manufactured by Bayer’s competitor, Boehringer-Ingelheim. Xarelto and Pradaxa are similar, but they work in different ways. Xarelto inhibits a protein involved in the coagulation process called Factor Xa, which interrupts the blood-clotting process and prevents another protein, thrombin, from forming. Pradaxa directly inhibits thrombin from forming.
CURRENT ANTICOAGULANT MARKET - $10 Billion - The current market for anticoagulants is estimated to be worth $10 billion, and many companies are developing newer drugs to get a piece of this market share. Previously, warfarin (Coumadin, Jantoven) was the industry standard anticoagulant. Because warfarin requires changes in diet and lifestyle, regular checkups, and has a risk of brain hemorrhage, drug companies developed and marketed oral medicines like Xarelto and Pradaxa as safer, more convenient alternatives.
HIGHER PER-PATIENT COST - $3000 Per Year - Although newer anticoagulants like Xarelto and Pradaxa are helpful to numerous patients, they are more costly than warfarin. Xarelto costs about $3,000 a year compared with $200 for warfarin. These drugs do not require frequent doctor checkups and have a uniform, “one-size-fits-all” dose. They can also have some very dangerous side effects that may lead to lawsuits.
If you or a loved one was injured by Xarelto, contact our Patient Advocates.
Side Effects of Xarelto
One of the most severe side effects of Xarelto is uncontrolled bleeding. When bleeding occurs near a major organ, such as the brain, lungs or kidneys, blood flow to that organ is interrupted, causing it to lose some or all of its functionality. Also, pools of blood may form within the body and can cause other severe health risks. Because Xarelto prevents clotting, the hemorrhaging will continue until the drug is flushed out of the system.
Like Pradaxa, Xarelto has no known antidote for uncontrolled bleeding, while warfarin does. The drug’s manufacturers have yet to release information for doctors on how to treat uncontrolled bleeding.
- Abdominal Bleeding
- Brain Hemorrhage
- Abnormal Liver Function
- Reduced Platelet Levels
Xarelto Uses and Clinical Studies
Original FDA Approval - Xarelto’s original FDA-approved use was as a blood thinner for patients recovering from knee or hip replacement surgery. Since then, the agency approved the drug to blood clots in patients with irregular heartbeat (atrial fibrillation) and to prevent reoccurring blood clots despite their own panel's disapproval.
Comparison to Warfarin - In 2011, the New England Journal of Medicine published the results of the ROCKET AF study that compared Xarelto to warfarin – a drug used for over 50 years – in patients with AF. The FDA said the study failed to show that Xarelto was more effective than warfarin. The drug is also known to cause more abdominal bleeding than warfarin.
No Antidote - While all blood thinners carry the risk of internal bleeding, older drugs like warfarin have emergency antidotes to prevent serious harm. Xarelto does not have an antidote, and the drug cannot be flushed out of the system through dialysis. People who suffer bleeding can end up hospitalized, and the bleed may be fatal..... ========>
See the full article Xarelto in Drugwatch.
© 2014 Drugwatch.com
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