Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011

BMC Clinical Pharmacology

Ebba Holme Hansen¹  Lise Aagaard¹ 

[1] Danish Pharmacovigilance Research Project (DANPREP), Copenhagen, Denmark

关键词: EudraVigilance;    Consumers;    Pharmacovigilance;    Nervous system medications;    Adverse drug reactions;   

Others  :  860587
DOI  :  10.1186/2050-6511-14-30

 received in 2012-10-18, accepted in 2013-06-11,  发布年份 2013

【 摘 要 】

Background

Reporting of adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. In the European Union, more countries have allowed consumers to report ADRs directly to the regulatory agencies. The aim of this study was to characterize ADRs reported by European consumer for nervous system medications.

Methods

ADRs reported by consumers for nervous system medications (ATC group N) from 2007 to 2011 and located in the European ADR database, EudraVigilance, were analysed. Data were categorized with respect to age and sex, category and seriousness of reported ADRs and medications. The unit of analysis was one ADR.

Results

We located 4766 ADRs reported for nervous system medications, and one half of these were serious including 19 deaths. Less than 5% of ADRs were reported in children. Totally, 58% of ADRs were reported for women, 42% for men. The majority of reported ADRs were of the types “nervous system disorders” (18% of total ADRs) followed by “psychiatric disorders” (18% of total ADRs) and “general disorders” (15% of total ADRs) which also were the system organ classes in which the majority of serious ADRs were found. ADR reports encompassed medicines from the therapeutic groups: antiepileptics (ATC group N03) (36% of total ADRs), parasympathomimetics (ATC group N07) (22% of total ADRs) and antidepressants ATC group N06A (9% of total ADRs). Antiepileptics were the therapeutic group with the highest share of serious ADRs (60%) followed by antidepressants (15%). Many serious ADRs were reported for pregabalin and varenicline.

Conclusions

The majority of ADRs from nervous system mediations reported by consumers that were identified from the EudraVigilance database were serious. The value of consumer reports in pharmacovigilance still remains unclarified.

【 授权许可】

   
2013 Aagaard and Hansen; licensee BioMed Central Ltd.

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