Gastrointestinal bleeds associated with direct oral anticoagulants (DOACs), which prevent stroke in atrial fibrillation, are under-reported based on Yellow Card reports, a UK study shows. 

The results illustrate that the use of the Yellow Card system “is poor, leading to under-reporting of adverse drug reactions”. The authors add that “it is crucial that all healthcare professionals encourage the use of the Yellow Card scheme”.

A district general hospital in North-West England recorded 12,013 emergency admissions related to GI bleeding during a five-year follow-up. Gastrointestinal bleeding contributed to about 6 per cent of emergency, non-maternity, non-elective admissions. Of those with gastrointestinal bleeding, 8.81 per cent of those admitted were taking a DOAC and 2.2 per cent received warfarin. However, the trust made only six Yellow Card submissions regarding DOACs during the same five years.

The authors comment that the study highlights “the need to investigate the reasons behind the long-recognised under- reporting using the Yellow Card Scheme, and to raise awareness of under-reporting using the scheme”.

International Journal of Clinical Pharmacy: doi.org/10.1007/s11096-023-01601-0