Xarelto Internal Bleeding Dangers on the Rise

This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm.

It appears yet another second-generation anticoagulant, Xarelto, is raising eyebrows over safety concerns.

A little background on Xarelto:

Rivaroxaban is an oral anticoagulant invented and manufactured by Bayer; in a number of countries, it is marketed as Xarelto. In the United States, it is marketed by Janssen Pharmaceutica.

In September 2008, Health Canada granted marketing authorization for rivaroxaban taken once daily for the prevention of venous thromboembolism (VTE) in patients who have undergone elective total hip replacement or total knee replacement surgery.

In September 2008, the European Commission granted marketing authorization of rivaroxaban for the same indication.

In December 2011, rivaroxaban was approved by the European Commission for use in two new indications: prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors, and for the treatment of deep venous thromboembolism. It was also approved for prevention of recurrent deep venous thromboembolism and pulmonary embolism (PE) following an acute deep venous thromboembolism in adults.

On July 1, 2011, the U.S. Food and Drug Administration (FDA) approved rivaroxaban for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adults undergoing hip and knee replacement surgery. On November 4, 2011, the U.S. FDA approved rivaroxaban for stroke prophylaxis in patients with non-valvular atrial fibrillation.

On November 2, 2012, theU.S. Food and Drug Administration(FDA) approved rivaroxaban for the treatment of patients with deep vein thrombosis (DVT) and pulmonary embolism(PE), as well as long-term treatment to prevent recurrence.
On May 24, 2013, the European Commission has given its approval to rivaroxaban for secondary prevention in adult patients who have had a biomarker-confirmed acute coronary syndrome (ACS). The indication is for 2.5-mg twice-daily in combination with standard antiplatelet therapy.

Safety Concerns Over Internal Bleeding:

German media reports last fall said that in the first 8 months of 2013 Bayer reported 968 side-effect reports to German regulators tied to the anticoagulant Xarelto, including 72 deaths. That was up from the 750 reports of adverse reactions and 58 deaths in all of 2012.

The number of side-effect reports onBayer’s anticoagulant drug Xareltoappears to be increasing, and some doctors are growing wary of using the drug as a standard first-line treatment, the German newspaper Der Spiegel reports. The increasing numbers follow the broader use of the drug, with Xarelto sales up 240% for the first half of the year–and a new European indication in acute coronary syndrome could keep the growth coming.

For the first 8 months of 2013, 968 side-effect reports were filed with Germany’s drug regulators, including 72 deaths. During all of the last year, the agency received 750 reports of adverse reactions, including 58 deaths, Der Spiegel says.

In the US, when people experience side effects they suspect were caused by a prescription or over-the-counter medicine, they or their doctors may report the events to the U.S. Food and Drug Administration (FDA). These events are recorded in the FDA Adverse Events Reporting System (AERS). A company called Adverse Events, Inc. has created special software that analyses the information in the AERS to provide detailed information about side effects experienced by patients across the U.S. There have been more than 2,100 total reports involving Xarelto, with 1,821 listing the drug as the primary suspect for an adverse event.

Of the more than 1,800 adverse events linked to Xarelto, the most common events were a pulmonary embolism (386 reports), deep vein thrombosis (279 reports), gastrointestinal hemorrhage (107 reports) and hemorrhage (107 reports). Other adverse events reported included thrombosis, hemoglobin decrease, cerebrovascular accidents, hematoma, edema peripheral and dyspnea. Hospitalization was reported in 891 of these events; 183 patients lost their lives.

Recently, the FDA rejected Xarelto use for the treatment of acute coronary syndrome, saying that the drug makers failed to show that the drug was both safe and effective. It was the third time the FDA had refused to expand Xarelto’s approved use.

Xarelto had sales of 949 million euros ($1.3 billion) last year and Bayer Chief Executive Marijn Dekkers has said he expected sales could reach around 3.5 billion euros annually.

If you or a loved were prescribed Xarelto and suffered an internal bleed, please contact The Michael Brady Lynch Firm for a free, no-obligation case evaluation.

About the Firm: The Michael Brady Lynch Firm is a trial firm with a focus on pharmaceutical mass tort cases involving SSRI and Anti-Seizure Medication Birth Defects including Lexapro, Zoloft, Effexor, Prozac, Celexa, Paxil, Depakote and Topamax, Testosterone cardiac events, Mirena IUD,  Actos Bladder Cancer, Lipitor diabetes cases, and medical device cases including DePuy Hip and Trans-Vaginal Mesh cases. Contact us today if you or someone you know has experienced side effects involving these products.

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