Case study: Rivaroxaban (Xarelto ▼) drug administration error

Background information

A A hospital pharmacist reported that a female patient had been taking 15mg of rivaroxaban treatment, twice daily for a diagnosed deep vein thrombosis (DVT, a blood clot in a deep vein). The woman took her medicine at home on an empty stomach – however, the patient information leaflet (PIL) states that ’you must take Xarelto together with a meal’ for both the 15mg and 20mg tablet forms. The woman ended up being admitted to hospital with shortness of breath. A CTPA was performed which diagnosed a pulmonary embolism (a blood clot in the lung). This proved that the rivaroxaban was not effective in preventing blood clots (anticoagulation) that it was prescribed for. 

Investigation

We carried out a through a routine safety review, we found two other Yellow Cards reports where patients were also taking the medicine on an empty stomach which caused a blot clot. 

We discussed the safety issue regarding taking rivaroxaban with food and noted that the patient information leaflet was in line with approved guidelines.  Because of the severity of harm that can be caused if the drug is taken with food, the pharmaceutical company was asked to update the product information for 15mg and 20 mg versions and make it clearer that these doses should be taken with food under the section called ‘How to take Xarelto ▼.’ 

Result

To increase awareness of this issue amongst healthcare professionals, a Drug Safety Update (DSU) article was published to remind them that Xarelto ▼ should always be taken with food. 

Additional information

Deep Vein Thrombosis (DVT) is a medical condition that occurs when a blood clot forms in a deep vein. These clots usually develop in the lower leg, thigh, or pelvis, but they can also occur in the arm. 

Computed tomography pulmonary angiogram (CTPA) Is a scan that looks for blood clots in the lungs. 

▼ symbolises this is a newer drug and therefore is under additional monitoring.  

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