Analysis of the Safety Profiles of Anticoagulants Using the EMA Pharmacovigilance Database

Introduction

Anticoagulants are widely used in the treatment of cancer-associated-thrombosis (CAT). Low molecular weight heparin (LMWH) has been the standard of care for years. However, recent data reported the use of direct oral anticoagulant (DOAC) in CAT patients with a higher rate of bleeding and more specifically a higher risk a gastrointestinal (GI) bleeding. The objective of this analysis is to investigate about the GI bleeding data in cancer and non-cancer patients.

Method

The public European database of suspected adverse drug reaction reports were checked in April 2019 for all the reports concerning DOACs and LMWHs available in Europe. These reports are submitted electronically by national medicines regulatory authorities and by pharmaceutical companies that hold marketing authorizations. A patients receiving an anticancer drug was considered as a cancer patients. All data from all patients regarding the GI haemorrhage.

Results

A total of 216 540 cases were found in the database. Gender (female: 46.5%, male: 45.6%, N/A: 7.9%). Most of the patients were > 65 years (63.8%). 32 591 cases for a LMWH and 183 949 for a DOAC. Among all, 2080 received an anticancer drug and 79 783 did not received an anticancer drug. Data about co-mediation were missing for all other cases. GI haemorrhages were common in both cancer (10.3%) and non-cancer patients (16.0%) receiving anticoagulants (Table 1).

Conclusion

GI haemorrhages were common in both cancer and non-cancer patients receiving anticoagulants, suggesting that GI haemorrhages may not only be linked to GI cancer. Furthermore, these data could suggest that patients receiving LMWH were less exposed to GI haemorrhages.

Table 1. GI bleeding in patients with anticoagulants.

Table 1

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Table 1

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