EMA Investigating Roche For Failure to Report Drug Side Effects

European drug regulators are investigating whether Roche failed to report side effects and problems associated with a number of different drugs, which may have been linked to more than 15,000 deaths. 

The European Medicines Agency (EMA) announced last week that it has launched a probe into the Swiss pharmaceutical company Roche. The investigation comes as the result of a May report from the UK Medicines Regulatory Agency (MHRA), after an inspection turned up 80,000 adverse event reports for Roche medicines marketed in the United States that had not been forwarded to European regulators.

The reports included 15,161 patient deaths, and the EMA says it is currently unclear whether those deaths were due to side effects of certain Roche drugs or from natural causes.

The EMA says that there is currently no evidence of a particular risk to patient health linked to the adverse event reports. It is also unclear whether any of the reports had been submitted through other channels, like through patients or doctors.

The EMA has called on Roche to ensure that all known adverse event reports are immediately reported to the appropriate European Union authorities and stipulated that Roche must confirm to the EMA that this has been done for both drugs at the clinical trial stage and for drugs already on the market.

Roche has also been required by the EMA to submit a comprehensive action plan by June 27, detailing how it will evaluate and report all of the outstanding cases and prevent a recurrence of its failure to report. The EMA stipulated that it was evaluating of each of the 80,000 unreported adverse event reports.

Roche officials have acknowledged that it was out of compliance with European Union reporting regulations and says that the error was not intentional. The company says it is pursuing corrective action.

Officially known as F. Hoffman-La Roche Ltd., the company is the producer of a number of blockbuster drugs, including Valium, Xenical, Avastin, Boniva and Tamiflu. The company brought in $42.5 billion in revenue in 2011.

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