Paul Flynn – 2016 Parliamentary Question to the Department of Health

The below Parliamentary question was asked by Paul Flynn on 2016-03-07.

To ask the Secretary of State for Health, how many instances of adverse reactions have been reported under the Yellow Card Scheme; and what the nature of the reaction reported was in the case of (a) dabigatran, (b) rivaroxaban and (c) apixaban.

George Freeman

Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines through the spontaneous reporting scheme, the Yellow Card Scheme. The scheme collects suspected ADR reports from the whole of the United Kingdom in relation to all medicines and vaccines. Reporting to the Yellow Card Scheme is voluntary for healthcare professionals and members of the public. There is also a legal obligation for pharmaceutical companies to report all serious ADRs for their products that they are aware of.

The table below provides the number of UK suspected spontaneous ADR reports received via the Yellow card Scheme in association with each drug substance as requested.

The information in the table shows the number of UK spontaneous suspected ADR reports in association with Dabigatran, Rivaroxaban and Apixaban up to and including 7 March 2016.

A full list of the type and number of reactions, broken down by the reaction term, is publically available for each medicine on the MHRA website. It is important to note that Yellow Card reports are not proof of a side effect occurring due to the medicine but only a suspicion by the reporter that the medicine may have caused the side effect. Yellow Card reports may therefore relate to true side effects of the medicine, or they may be due to coincidental illnesses that would have occurred in the absence of the medicine.

Dabigatran, rivaroxaban and apixaban are anticoagulant medicines used to prevent or treat blood clots. The most commonly reported adverse reaction for all three medicines is gastrointestinal haemorrhage or bleeding, which is in keeping with the known anticoagulant effects of these medicines. Other relatively commonly reported suspected adverse reactions include bleeding at other sites of the body, gastrointestinal symptoms (such as nausea, pain and diarrhoea), anaemia, and rash. These adverse reactions are described in the product information, in both the Patient Information Leaflet for patients and the Summary of Healthcare Products for healthcare professionals.