ROCHE esconde.../ "podría no curar sino matar"

"These included 15,161 deaths,
which may have been due
to natural disease progression
but may have been connected to the drugs.
More recent information from the company
indicated fewer reports,
but this needed to be verified, the agency said".

Ver

By Ben Hirschler LONDON | Thu Jun 21, 2012 4:47pm EDT

(Reuters) - The European Medicines Agency said on Thursday it was investigating Swiss group Roche Holding AG after a routine inspection found it had failed to properly assess 80,000 cases of possible adverse drug reactions.

The issue relates to medicines from across the Roche product range that were part of a financial reimbursement system in the United States.

Roche is the world's largest maker of cancer medicines and it also produces drugs for viral infections, central nervous system disorders and inflammatory diseases.

"There is at present no evidence of a negative impact for patients and while the investigations are being conducted there is no need for patients or healthcare professionals to take any action," the agency said in a statement.

The move was triggered by a routine check by British regulators that found Roche had not properly evaluated around 80,000 reports linked to a company-sponsored patient support program dating back to 1997 to see if they should be reported as suspected adverse reactions.

These included 15,161 deaths, which may have been due to natural disease progression but may have been connected to the drugs. More recent information from the company indicated fewer reports, but this needed to be verified, the agency said. (Más)

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Detectan irregularidades en medicamentos Roche por 80 mil informes no notificados