ABSTRACT
INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health Authority. The aim of this retrospective observational study was to quantify and describe ADRs reported via the ADEM in 2014. METHODS: All ADR reports handled by the ADEM in 2014 were recorded anonymously and analysed descriptively. RESULTS: A total of 484 ADRs were reported through the ADEM in 2014 (the median number of reports per month was 37; range: 17-78). The majority of the reports came from departments of internal medicine (61%), psychiatry (14%) and dermatology, ophthalmology or otorhinolaryngology (11%). The drugs most frequently reported were lisdexamphetamine (n = 40), rivaroxaban (n = 16) and warfarin (n = 15) (vaccines excluded). In 13 out of 484 reports, the ADR was associated with a fatal outcome. CONCLUSION: The findings of this study indicate that an ADEM promotes and facilitates spontaneous ADR reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad. FUNDING: none. TRIAL REGISTRATION: not relevant. .
Subject(s)
Adverse Drug Reaction Reporting Systems/statistics & numerical data , Hospital Departments/statistics & numerical data , Hospitals/statistics & numerical data , Adolescent , Adult , Aged , Aged, 80 and over , Anticoagulants/adverse effects , Central Nervous System Stimulants/adverse effects , Child , Child, Preschool , Denmark , Dermatology/statistics & numerical data , Factor Xa Inhibitors/adverse effects , Female , Humans , Infant , Infant, Newborn , Internal Medicine/statistics & numerical data , Lisdexamfetamine Dimesylate/adverse effects , Male , Middle Aged , Ophthalmology/statistics & numerical data , Otolaryngology/statistics & numerical data , Product Surveillance, Postmarketing/methods , Psychiatric Department, Hospital/statistics & numerical data , Retrospective Studies , Rivaroxaban/adverse effects , Warfarin/adverse effects , Young AdultABSTRACT
A 17-year-old male with ADHD who was treated with sertraline and lisdexamfetamine presented with transient episodes of speech impairment and right-sided hemiparesis preceded by headaches. Magnetic resonance imaging revealed three cerebral ischaemic lesions. Treatment was initiated with aspirin and discontinued with lisdexamfetamine. In the literature a causal relationship between treatment with central stimulants and the development of cerebrovascular events has not been substantiated. Vasospasm and paroxystic tachycardia may be associated with the event, but lisdexamfetamine and sertraline cannot be ruled out as risk factors.
