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FDA Approves New XARELTO® Use


Philadelphia XARELTO® lawyer will fight for patients harmed by this dangerous drug.Although it is classified as a blood thinner/Factor Xa inhibitor, the anti-coagulant drug XARELTO® has been approved by the U.S. Food and Drug Administration (FDA) for another use. A recent report shows that it can be taken to reduce the risks of peripheral artery disease (PAD), chronic coronary disease (CAD), strokes, other cardiovascular events, and cardiovascular death. XARELTO® is the only Factor Xa inhibitor-classified drug that has been approved by the FDA for this.

A clinical study referred to as COMPASS surveyed over 27,000 patients from around the world with PAD or CAD. It focused on XARELTO® use alone, or combined with aspirin, and its effects on long-term cardiovascular event prevention.

The results showed a 24 percent risk reduction, a 14 percent heart attack risk reduction; a 22 percent cardiovascular event death risk reduction; and a 42 percent stroke risk reduction.

An article about this COMPASS study was printed in The New England Journal of Medicine in 2017. It concluded that among the test subjects, those taking 5 mg of XARELTO® per day, and aspirin, had better cardiovascular results and increased major bleeding occurrences as compared to the patients who were only taking aspirin.

Causes of PAD and CAD

When cholesterol and plaque build up in the human body, arteries can narrow and get hardened; this is known as atherosclerosis. This may limit the blood flow and is the main cause of PAD and CAD. In the United States approximately 16.5 million people have one of these diseases, and not all of them are diagnosed. Those that do not get treatment can experience a stroke, a heart attack, or even death.

This drug was introduced in 2011. It is marketed by the Janssen Pharmaceutical Companies of Johnson & Johnson. The Vice President, Medical Affairs, Internal Medicine of Janssen Scientific Affairs, LLC said that patients with chronic PAD and CAD still face the danger of life-threatening cardiovascular events, even if they are in treatment. He explained that XARELTO® now has a 2.5 mg pill, which, when combined with aspirin twice a day, can effectively reduce the risks.

Side Effects

Like any other drug, XARELTO® does have side effects. In 2013, the FDA distributed a warning letter about XARELTO®. At the time, the FDA believed that the drug’s risks were being downplayed in the media. Two of the main ones are a risk for bleeding and blot clots. This danger in increased for patients that take XARELTO® while also taking aspirin, non-steroidal anti-inflammatories (Advil, Aleve), heparin, Plavix, certain serotonin inhibitors (Prozac, Zoloft), and other drugs.

Symptoms to be aware of include severe bleeding, frequent nosebleeds, black or bright red stools, dark urine, coughing up or throwing up blood, dizziness, headaches, pain, or hematomas.

Certain patients may not be able to take XARELTO®, including individuals that are prone to bleeding, have kidney or liver problems, and pregnant or breastfeeding women. In addition, anyone taking this drug must always inform their doctor, surgeon, or dentist before any procedure is initiated.

A Philadelphia XARELTO® Lawyer at Brookman, Rosenberg, Brown & Sandler Will Fight for Patients Harmed by XARELTO®

Prescription drugs are not supposed be harmful. If you or someone you care for has been adversely affected by prescription drugs like XARELTO®, you need legal guidance from a professional Philadelphia XARELTO® lawyer at Brookman, Rosenberg, Brown & Sandler. Call us today at 215-569-4000 or contact us online. We represent clients in Delaware County, Chester County, Philadelphia County, Pennsylvania, and New Jersey.