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Dabigatran-Induced Nephropathy and Gastrointestinal Bleeding and Its Successful Treatment with Idarucizumab: A Case
Francesca Marchesini1, Andrea Ossato2, Alberto Zendrini1
1IRCCS Ospedale Sacro Cuore Don Calabria, Negrar di Valpolicella, Italy.
Insights
Non-vitamin K antagonist oral anticoagulants (NOACs) are recommended for atrial fibrillation stroke prevention. A rare, delayed reaction of gastrointestinal bleeding and nephropathy occurred 27 months after starting dabigatran, highlighting the need for monitoring.
Area of Science:
- Pharmacology and Toxicology
- Cardiology
- Nephrology
Background:
- Updated atrial fibrillation guidelines recommend Non-vitamin K antagonist oral anticoagulants (NOACs) over warfarin for stroke prevention.
- NOACs offer pharmacologic advantages but can cause gastrointestinal bleeding and nephropathy, typically within weeks of initiation.
Purpose of the Study:
- To report the first case of a chronic, delayed adverse reaction to dabigatran.
- To emphasize the importance of hospital pharmacy supervision and patient monitoring in NOAC therapy.
Main Methods:
- Case report of an 82-year-old woman experiencing adverse effects 27 months after starting dabigatran (110 mg twice daily).
- Observation of concomitant gastrointestinal bleeding and nephropathy.
- Administration of idarucizumab to assess its effect on bleeding and renal parameters.
Main Results:
- The patient developed chronic gastrointestinal bleeding and nephropathy 27 months into dabigatran therapy.
- Idarucizumab administration led to immediate improvement in both bleeding and renal function.
- Lack of consistent laboratory monitoring and supervision by hospital pharmacy was noted.
Conclusions:
- A rare, delayed-onset adverse reaction of gastrointestinal bleeding and nephropathy can occur with dabigatran.
- Idarucizumab can effectively manage such acute complications.
- Continuous supervision by hospital pharmacy and adherence to therapeutic plans are crucial for safe NOAC use.
Abstract:
Recently, the atrial fibrillation treatment guidelines have been updated to now recommend Non-vitamin K antagonist oral anticoagulants (NOACs) as the preferred alternative to warfarin for systemic embolism and stroke prevention in patients with non-valvular atrial fibrillation. NOACs have major pharmacologic advantages over warfarin, although the most common complications are gastrointestinal bleeding and NOAC-induced nephropathy within 6 weeks after starting therapy, as several recent case-reports stated. We are reporting for the first time a chronic delayed adverse reaction (regularly reported to Authorities) observed in an 82-year-old woman 27 months after starting dabigatran (110 mg twice a day), characterized by concomitant gastrointestinal bleeding and nephropathy. Idarucizumab administration immediately improved both bleeding and renal parameters. Moreover, we are going to highlight the importance of the compliance, the adherence to the therapeutic plan and the supervision of the Hospital Pharmacy on drug prescriptions. In fact in our case, dabigatran was firstly prescribed by the neurologist and delivered by the hospital pharmacy, but the patient continued the treatment for 27 months, prescribed by general practitioner without any laboratory control. This lack of supervision certainly contributed to the onset of the adverse reaction reported.
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