Thursday - November 10, 2016
Not intended for U.S. and UK Media

Bayer comments on article in „Handelsblatt“ regarding the anticoagulant Xarelto®

Health authorities in Europe and the U.S. have confirmed the positive benefit-risk profile of Xarelto / Potential malfunctioning of the monitoring devices did not affect the study results / During the pivotal trial, the monitoring devices were approved for use by the health authorities and CE certified / Management of bleeding is established for the novel anticoagulants as well / Novel anticoagulants represent medical progress and have proven themselves in clinical practice

Leverkusen, November 10, 2016 – The “Handelsblatt” has published an article in connection with the anticoagulant Xarelto® (Rivaroxaban) from Bayer on November 9, 2016 that includes misleading statements. This article may result in patients stopping the intake of their anticoagulant without first consulting their physician, thereby potentially increasing their stroke risk. Bayer would therefore like to set the facts right and stress that if patients have any questions about Xarelto to first consult their doctor.

With regards to the article, Bayer comments as follows:

Anticoagulants of the new generation like Xarelto® (Rivaroxaban) from Bayer can protect people from having a stroke or other life-threatening vascular occlusions. They were developed to improve stroke prevention. For decades, vitamin K antagonists (VKA) were the main agents available for these areas of application. Given that it is challenging to treat patients within the therapeutic range of VKAs, routine coagulation monitoring as well as frequent dose adjustments are required. Due to the challenging nature of VKA therapy, the approval of the novel oral anticoagulants (NOAC) was viewed as medical progress.

NOACs deliver a reliable anticoagulation effect in fixed dosages without the need for frequent dose adjustments. Routine coagulation monitoring like is done for VKAs is therefore not required medically for the NOACs nor for many other antithrombotic drugs, like e.g. ASA. In addition, NOACs have safety advantages while providing similar efficacy: In the area of stroke prevention, NOAC treatment is associated with less fatal bleeding and less intracranial bleeding compared to VKA therapy. NOACs have been approved by health authorities worldwide based on the clinical trials demonstrating a positive benefit-risk profile.

Management of bleeding events is established for the NOACs like rivaroxaban as well. When reversal of the anticoagulation activity of Xarelto is necessary, stopping the drug allows for normalisation of coagulation parameters. This requires a similar timeframe as giving vitamin K to patients receiving a vitamin K antagonist. Additionally, should more rapid normalisation be required to manage rare emergency situations, drugs stimulating coagulation can be used. These drugs are not specific for rivaroxaban and can be used for VKAs as well.

In total three medical societies, amongst them the European Society for Cardiology (ESC), recommend the novel oral anticoagulants as broadly preferable to VKAs in the vast majority of patients with non-valvular atrial fibrillation (AF), stating that novel oral anticoagulants (NOACs) offer a better benefit-risk profile. Atrial fibrillation is common in people over the age of 65 and increases the risk of stroke fivefold. The ESC's latest recommendation, published in August 2016, is based amongst others on the pivotal trials as well as a meta-analysis in which the NOACs have proven their effectiveness and safety in comparison to VKA.

During the conduct of the ROCKET AF trial (2006-2010), the INR devices were approved for use by the FDA and available on the market in the USA and EU (CE certification). The European and American Health Authorities have confirmed that a potential malfunctioning of the Alere monitoring device did not impact the conclusions of the ROCKET-AF trial. Following review of all information provided, the EMA concluded in their February 2016 assessment report on this topic that Janssen and Bayer were “not aware of any potential impact of the identified deficiencies of the INR device system of the ROCKET studies until September 9, 2015.” Bayer and its partner Janssen Research & Development, LLC have ensured and will continue to ensure that health authorities receive all required information regarding past and ongoing clinical trials.

Bayer is continuously evaluating the efficacy and safety profile of its anticoagulant. Since launch, the efficacy and safety profile has been consistent with the results of the clinical trials, which involved more than 85,000 patients. Studies from routine clinical practice confirm the positive benefit-risk profile across the approved indications. The Bayer product is already the most extensively tested drug amongst the NOACs. By the time of its completion, the program is expected to include more than 275,000 patients in both clinical trials and real world settings across all indications.

As of October 14, 2016, U.S. lawsuits from approximately 13,800 recipients of Xarelto™, an oral anticoagulant for the treatment and prevention of blood clots, had been served upon Bayer. Plaintiffs allege that users have suffered personal injuries from the use of Xarelto™, including cerebral, gastrointestinal or other bleeding and death, and seek compensatory and punitive damages. Bayer believes it has meritorious defences and intends to defend itself vigorously.

Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral anticoagulant and is marketed under the brand name Xarelto®. Xarelto is approved for seven indications, protecting patients across more venous and arterial thromboembolic (VAT) conditions than any other NOAC.

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Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2015, the Group employed around 117,000 people and had sales of EUR 46.3 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.3 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to

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