Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

Gastrointestinal bleedings during therapy with new oral anticoagulants are rarely reported

Research output: Contribution to journalJournal articleResearchpeer-review

  1. Characteristics of patients with COVID-19 pneumonia at Hvidovre Hospital, March-April 2020

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Trends of ankyloglossia and lingual frenotomy in hospital settings among children in Denmark

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Distribution of risk alleles in patients with age-related macular degeneration

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Outcomes and follow-up programmes in extreme preterm children in Denmark in the EPICE/SHIPS cohort

    Research output: Contribution to journalJournal articleResearchpeer-review

  5. Risk of pancreatitis in patients with inflammatory bowel disease - a meta-analysis

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Large Incisional Hernias Increase in Size

    Research output: Contribution to journalJournal articleResearchpeer-review

View graph of relations

INTRODUCTION: Post-marketing surveillance of drugs relies on spontaneous reporting of adverse drug events to the Danish Health and Medicines Authority. A number of new oral anticoagulants (NOAC) have recently been marketed in Denmark. The purpose of this study was to evaluate the reporting of serious adverse drug events in patients treated with a NOAC and admitted for gastrointestinal bleeding.

METHODS: This study is based on an electronic free text search in patient records and a search in the electronic medication records of all patients admitted to the Department of Gastroenterology, Surgical Section, Hvidovre Hospital, during a one-year-period. Patients in treatment with NOAC and admitted for gastrointestinal bleeding were identified. Relevant patients were cross-checked for a reported adverse drug event in the Danish Health and Medi-cines Authority's database on adverse medical events.

RESULTS: A total of 20 patients were acutely admitted for gastrointestinal bleeding while in treatment with a NOAC, an adverse medical event was reported for one of these patients (5%; 95% confidence interval: 0-25%).

CONCLUSION: Serious adverse events in patients treated with NOAC are underreported which questions the current effectiveness of post-marketing surveillance of adverse drug effects.

FUNDING: not relevant.

TRIAL REGISTRATION: The study was registered with clin-icaltrials.gov (NCT02107651).

Original languageEnglish
JournalDanish Medical Bulletin (Online)
Volume61
Issue number11
Pages (from-to)A4952
ISSN1603-9629
Publication statusPublished - Nov 2014

ID: 44841916