Saturday, August 30, 2014

Novartis fails to report side effects, fatality

Jiji PressNovartis Pharma K.K. said it has failed to report to the health ministry at least 2,579 cases of serious side effects, including a fatality, from its drugs for leukemia and other diseases even though its employees were aware of the problems.

Of the total, 1,313 cases were related to Glivec and 514 cases to Tasigna, both drugs for leukemia treatment, and 261 cases involved cancer drug Afinitor, said the Japanese unit of Swiss drug giant Novartis AG on Friday.

The findings were reported to the Health, Labor and Welfare Ministry the same day.

Marketing employees at the firm had recognized the side effects, but failed to report them to its division in charge in violation of its internal rules, Novartis Pharma said. They were not fully aware of the seriousness of the problem, while higher-ranking officials failed to supervise them properly, it said


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