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Xarelto® Surpassing Pradaxa® in Number of Adverse Event Reports, according to Recent ISMP Quarter Watch Report

Kristine Kraft

According to the Institute for Safe Medication Practices’ (ISMP) most recent Quarter Watch Report, Xarelto® (rivaroxaban) has overtaken Pradaxa® (dabigatran) in the number of reported adverse events, including serious bleeding events.

The ISMP reports that in 2013, the U.S. Food and Drug Administration (FDA) reported receiving 680 serious adverse event reports from individuals who alleged to have suffered adverse events while taking the anticoagulant drug Xarelto® (rivaroxaban), while only 528 serious adverse events were reported for Pradaxa® (dabigatran). The FDA’s Adverse Event Reporting System (FAERS) remains the cornerstone of postmarket safety surveillance, the mechanism through which most significant drug risks are detected once a drug has been approved and is available on the market.

The anti-clotting medication Xarelto®, which is marketed by Johnson & Johnson in the United States and by Bayer outside the United States, was approved by the Food and Drug Administration (FDA) in July 2011 for use in patients who recently underwent hip or knee replacement surgery to reduce the risk of blood clots. According to a press release issued by the FDA, in November 2011 the FDA approved another indication of Xarelto® for patients with atrial fibrillation (AF) to reduce the risk of stroke. Then in 2012, according to another press release issued by the FDA, the FDA approved another indication of Xarelto® expanding its use for the general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).

“We are concerned about the increasing number of adverse events associated with Xarelto®,” said Kristine Kraft, partner at Schlichter, Bogard & Denton, LLP. She adds, “We will fight for the rights of individuals who allege to have experienced serious and life-threatening injuries after using Xarelto® and our office is offering free and confidential case reviews to those who allege to have suffered injuries.”

 

About Schlichter, Bogard & Denton, LLP
Schlichter, Bogard & Denton, LLP is a unique law firm that has held numerous leadership positions in national litigations involving dangerous pharmaceutical medications and unsafe medical devices, including but not limited to: In re: Pradaxa® (Dabigatran Etexilate) Products Liability (MDL 2385, Case No. 12-md-2385, S.D. Ill.), In re: Yasmin® and Yaz® (Drospirenone) Marketing and Sales Practices and Products Liability Litigation (MDL 2100, Case No. 09-md-2100, S.D. Ill.), In re: NuvaRing® Products Liability Litigation (MDL 1964, Case No. 08-md-1964, E.D. Mo.), In re: Gadolinium-Based Contrast Products Liability Litigation (MDL 1909, Case No. 08-gd-50000, N.D. Ohio), and In re: Ortho Evra® Products Liability Litigation (MDL 1742, Case No. 06-gd-40000, N.D. Ohio).

The Pharmaceuticals and Medical Litigation Department at Schlichter, Bogard & Denton, LLP aggressively represent clients who allege to have suffered injuries as a result of dangerous pharmaceutical medications and unsafe medical devices. The attorneys who represent such victims include Roger Denton, Kristine Kraft, Beth Wilkins Flieger, Ashley Brittain Landers, and Tara Rocque. With hard work, creative thinking, and strong trial skills, we have earned an outstanding nationwide reputation by representing thousands of individuals who have suffered serious and life-threatening injuries, or even death.

If you or a loved one has suffered serious injuries after using Xarelto®, please contact the attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.

Schlichter, Bogard & Denton, LLP also welcomes the opportunity to work with other attorneys on these types of cases. We are available to either handle these cases or work as co-counsel, so other attorneys with these types of cases are invited to contact an attorney at the firm to explore this opportunity.

 

The choice of a lawyer is an important decision and should not be based solely on advertisements. The cases discussed do not predict outcomes in future cases. Past results afford no guarantee of future results and every case is different and must be judged on its own merits.

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