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<p>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.</p><p> </p><p>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.</p><p>
</p><p>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.</p><table><tbody><tr><td><p>Drug substance</p></td><td><p>Number of
reports</p></td></tr><tr><td><p>Dabigatran</p></td><td><p>1,552</p></td></tr><tr><td><p>Rivaroxaban</p></td><td><p>3,291</p></td></tr><tr><td><p>Apixaban</p></td><td><p>900</p></td></tr></tbody></table><p>
</p><p> </p><p>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.</p><p> </p><p>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.</p><p> </p><p><strong> </strong></p><p><strong>
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