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EMEA to publish side effects data

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EU health regulators have given into pressure from the European Ombudsman and agreed to publish data on drug side effects.

A spokesman for the European Medicines Agency (EMEA) said the move would improve transparency and accountability. Some experts believe it will also make it easier for consumers to sue pharmaceutical companies.

Information on the side effects of Accutane, Roche’s acne drug, will be published “within the next few weeks”, the agency said, following complaints from an Irish woman whose son committed suicide while on the medication.

The EMEA had argued that concerns over patient confidentiality meant it did not have to obey EU disclosure rules.

The new system ensures personal data is deleted before reports are published.

Accutane has had a controversial history since being launched in 1982. While good at clearing acne, the drug has been linked to birth defects and psychological problems.

Roche, which has always rejected such claims, stopped selling the drug last year, blaming generic competition.

Copyright Press Association 2010

European Medicines Agency

Roche



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