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Xarelto▼ (rivaroxaban) - patient safety update

Xarelto▼, for Angina, Atrial fibrillation, Deep vein thrombosis (DVT), Heart attack, Myocardial infarction, Pulmonary embolism, Stroke and Unstable angina from Bayer

The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a reminder that Bayer's anti-coagulant medicine rivaroxaban, brand name Xarelto▼, 15 mg and 20 mg tablets should be taken with food. The MHRA has received a small number of reports of patients taking rivaroxaban 15 mg or 20 mg who experienced a thromboembolic event, which the reporter suspected was due to the patient taking the tablets on an empty stomach.

Thromboembolic events arise from the formation in a blood vessel of a clot (thrombus) that breaks loose and is carried by the blood stream to plug another vessel. The clot may plug a vessel in the lungs (pulmonary embolism), brain (stroke), gastrointestinal tract, kidneys, or leg.

The section of the patient leaflet for rivaroxaban 15 mg and 20 mg tablets that advises patients how to take their medicine has been revised to emphasise patients must take rivaroxaban with a meal and the tablets should be swallowed preferably with water.

You can follow developments with Xarelto by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

About Xarelto (source EMA)
Xarelto is an anticoagulant medicine (a medicine that prevents blood clotting) used in adults:
  • to prevent venous thromboembolism (VTE, the formation of blood clots in the veins) in patients who are undergoing surgery to replace a hip or knee;
  • to prevent stroke (caused by a blood clot in the brain) and systemic embolism (a blood clot in another organ) in patients with non-valvular atrial fibrillation (irregular rapid contractions of the upper chambers of the heart);
  • to treat deep vein thrombosis (DVT, a blood clot in a deep vein, usually in the leg) and pulmonary embolism (a clot in a blood vessel supplying the lungs), and to prevent DVT and pulmonary embolism from re-occuring.
  • to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) after an acute coronary syndrome. Acute coronary syndrome is a group of conditions that includes unstable angina (a severe type of chest pain) and heart attack. Xarelto is used together with antiplatelet medicines, which prevent the formation of blood clots.
Xarelto contains the active substance rivaroxaban.

The active substance in Xarelto, rivaroxaban, is a ‘factor Xa inhibitor’. This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin. Thrombin is central to the process of blood clotting. By blocking factor Xa, the levels of thrombin decrease, which reduces the risk of blood clots forming in the veins and arteries, and also treats existing clots.

Xarelto was first made available in the EU in 2008. It is manufactured by Bayer.

Sources
European Medicines Agency website page for Xarelto
Accessed 19/07/19
Links available in full article

MHRA information for Xarelto

New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected adverse drug reactions (ADRs) for these products. ADRs can be reported by your doctor, pharmacist or online via the Yellow Card system.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


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