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Drug safety

EMA expands public access to suspected drug side effect data

The public now has access to a website containing reports of suspected side effects of drugs that were authorised by medicines safety regulators in European Union member states.

Before now, the database, managed by the European Medicines Agency, only held data on the suspected side effects of drugs that had been centrally authorised. Information related to an additional 1,700 substances has been added to the database.

“Roll-out of public access to suspected side effects related to all medicines available in the EU will occur gradually over the next few years,” the EMA says.

The information made available through the public website comes directly from EudraVigilance, a database of reports on suspected drug side effects submitted by regulatory authorities and pharmaceutical companies.

The aggregated data can be viewed by age group, sex, type of suspected side effect and outcome. 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20066754

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