[Ip-health] Drugmaker Novartis fails to report side effects linked to Tasigna
hd at bukopharma.de
Tue May 13 00:47:13 PDT 2014
Novartis Pharma K.K. failed to inform the government of at least 10 suspected cases of serious side effects involving its Tasigna leukemia drug, it was learned Friday.
The Health, Labor and Welfare Ministry has opened an investigation into whether the Novartis unit broke the pharmaceutical affairs law, sources said.
The Japanese unit of Swiss drug giant Novartis AG conducted a questionnaire with doctors between April 2013 and January this year to collect information on some 3,000 patients who use Tasigna, according to the company and other sources.
The questionnaire revealed some 30 suspected cases of serious side effects, with at least 10 of these subject to a duty to report stipulated by the law, the sources said.
But Novartis left the Tasigna cases unreported - until recently, the sources said. Sales representatives were aware of the side effect data produced by the questionnaire but did not report it to the corporate department in charge of the matter, according to the sources.
Two similar cases also came to light in connection with a scandal over the drugmaker's inappropriate involvement in clinical trials. But these were later found not to be covered by the legal obligation, according to the ministry.
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