Tokyo-based Novartis Pharma K.K. said employees have failed to report up to 10,000 cases of serious side effects caused by its drugs for leukemia and other diseases to an internal department since 2002.
The Japanese unit of Swiss drug giant Novartis AG found this as a result of an in-house probe covering all 4,500 employees that was conducted following the revelation that workers were improperly involved in clinical trials for leukemia drugs at medical institutions.
The reporting failure violated in-house rules, according to the company.
The 10,000 cases are believed to include ones that should have been reported to the government. All of the cases had been reported to the Health, Labor and Welfare Ministry by Monday, the company claimed. Novartis Pharma said the unreported cases are now being examined in detail.