Xarelto (rivaroxaban), a new blood-thinning medication, has recently been approved to prevent stroke in people with atrial fibrillation, but questions remain about the safety and effectiveness of this medication. People with acute illnesses taking Xarelto may be twice as likely to develop a blood clot. Experts have also questioned the amount and quality of the safety data that the drug-maker has provided to regulators.

The U.S. Food and Drug Administration (FDA) approved Xarelto in July 2011 for a small pool of people — those who had knee or hip replacement surgery — because they are at a higher risk of developing blood clots that could lead to a stroke or pulmonary embolism.

It was anticipated that the FDA would approve Xarelto for much broader clot-prevention use, and in November 2011, Xarelto was approved to prevent stroke in people with abnormal heart rhythm, also known as non-valvular atrial fibrillation. Atrial fibrillation is caused by an irregular heartbeat rhythm between the upper and lower chambers of the heart, which can cause blood to pool in the upper chambers. If this pooled blood forms a clot, the heart could pump it to the brain, which could block the blood vessel and cause a stroke.

More than 2 million Americans have abnormal heart rhythm and would potentially buy a drug like Xarelto, which can prevent blood clots and strokes caused by abnormal heart rhythm.

Widespread use of Xarelto in this population could mean billions in profit for the drug-maker. But there is concern over the safety and efficacy of Xarelto.

Higher Bleeding Risk Seen in Xarelto Patients with Acute Illnesses

In April 2011, a study of more than 8,000 people compared Xarelto to Lovenox in patients hospitalized for acute medical conditions, such as heart failure, infectious disease, and breathing difficulty.

Lovenox is typically given as an injection to prevent blood clots, usually for no more than two weeks. The study compared Xarelto to Lovenox used over 10 days, and found the two medications equally effective.

The study was then extended to 35 days to compare long-term effectiveness. Some patients were given Xarelto for 35 days. Some were given Lovenox for 10 days, and then a placebo for the remaining 25 days.

Patients taking Xarelto had significantly higher rates of bleeding — they were more than twice as likely to experience bleeding compared to Lovenox. 4.1% of patients taking Xarelto experienced bleeding, compared to 1.7% taking Lovenox.

Xarelto “ROCKET” Safety Study

The biggest clinical trial of Xarelto evaluated more than 14,000 patients, and compared Xarelto to warfarin. The study found that Xarelto was no more effective than warfarin, and the risks were comparable. The most common side effect was bleeding, with rates comparable to warfarin. It caused less bleeding in the brain and more bleeding in the stomach and intestines.

The safety and effectiveness of Xarelto has been questioned, after an editorial in the New England Journal of Medicine found that the use of multiple statistical analyses “muddied the waters” when it came to determining the drug’s safety.

One of the three FDA reviewers who examined the data found that the drug-makers failed to administer warfarin in an optimal way, which may have skewed the data.

Furthermore, FDA staff recommended against approving Xarelto for use in patients with atrial fibrillation, because the results of the ROCKET study do not clearly demonstrate the safety or effectiveness of the medication compared with warfarin. The reviewers recommended that an additional study is needed to clarify potential stroke and bleeding risks.

UK Agency Asks for More Xarelto Safety Data

Reuters reports on January 9, 2012 that Britain’s National Institute for Health and Clinical Excellence (NICE) is asking Bayer to provide more safety data before it can recommend the drug for use in the state health services.

NICE said that the data Bayer had already provided was not sufficient to determine safety or efficacy of Xarelto. Because of the lack of data, the organization decided not to recommend the drug.

In November 2011, NICE approved the use of Pradaxa for stroke prevention after the company provided additional safety information. The organization also approved Eliquis, but only in patients who had recently undergone knee and hip replacement surgery.

Xarelto, Pradaxa, Eliquis, and Lixiana in a Race to Replace Warfarin and Dominate $20BN Market

The war over the multi-billion-dollar market for anti-stroke medications is heating up, as several major pharmaceutical companies push new drugs as alternatives to warfarin, a blood-thinning medication that has long dominated the stroke-prevention market. Warfarin is relatively inexpensive, but interacts with many foods and requires frequent blood testing to adjust the dosage.

The race for a safer, more user-friendly medication could potentially yield billions in profit. More than 2.2 million Americans and 4.5 million people in the European Union have atrial fibrillation, a type of irregular heartbeat that can cause blood clots that lead to stroke. The market for bloodthinners is estimated to be worth between $15-20 billion.

Pfizer and Bristol-Myers Squibb, which released data in September 2011 that showed its drug, Eliquis (apixaban) caused less bleeding and fewer deaths than warfarin. Boehringer Ingelheim has already launched its drug Pradaxa (dabigatran) with an aggressive marketing campaign. Lixiana (edoxaban) is an oral anticoagulant drug in development by Daiichi Sankyo in Japan.

How do I contact a Xarelto Lawyer for a Xarelto Lawsuit?

The Schmidt Firm, LLP is currently accepting Xarelto induced injury cases in all 50 states. If you or somebody you know has experienced a side effect after taking Xarelto, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Xarelto Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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