Physicians and patients who want to track the safety of pharmaceuticals in Europe have a new resource with the launch of a public website. Reports published on the site are derived from EudraVigilance, the drug safety database used by European Union (EU) regulators to monitor benefits and risks of a medicine once it has been approved.
The European Medicines Agency (EMA), which is publishing the reports, announced May 31 that it has begun offering reports on suspected adverse reactions to drugs as part of its effort to maintain transparency in EU regulatory processes.
Information on the website is presented in the form of a single report per medicine or active substance. Each report pulls together the total number of individual suspected side effect reports submitted to EudraVigilance by member states and marketing-authorization holders. The aggregated data can be viewed by age group, sex, type of suspected side effect and by outcome.
Adverse drug reactions include side effects from use of a medicine within the terms of the marketing authorization as well as from use outside the terms of the marketing authorization, including overdose, misuse, abuse and medication errors, and those associated with occupational exposure. Suspected side effects may not be related to or caused by the medicine, and as a result, the published information cannot be used to determine the likelihood of experiencing a side effect or as an indication that a medicine is harmful.
The initial round includes information published on approximately 650 medicines and active substances. According to the EMA, additional published reports of suspected adverse effects for common drug substances used in nationally authorized medicines will become available in the future.
The reports are available here.