The Health, Labor and Welfare Ministry issued a business improvement order Thursday to Novartis Pharma K.K. for its failure to report serious side effects of its leukemia treatment drugs.
The Tokyo-based unit of Swiss drug giant Novartis AG did not report serious side effects of the firm’s Glivec and Tasigna drugs before the deadline, although it was aware of 21 cases of serious side effects suffered by 16 patients, according to the ministry and other sources.
The company learned about the side effect cases in a survey of doctors and clinical trials in which employees were involved.
This was the first administrative punishment over a report about drug side effects, according to the ministry.
The pharmaceutical affairs law obliges drugmakers to report serious drug side effects to the government within 30 days of becoming aware of them, at the latest.
While the side effects, including subdural hematoma and cerebral hemorrhage, did not lead to deaths, some 190 Novartis Pharma employees in charge of sales failed to inform the relevant departments of information they acquired on possible side effects. Necessary reports to the government were overdue for a maximum 50 months.
The ministry ordered Novartis Pharma to establish a system to ensure side effect reports reach the relevant departments and provide training to employees. The company was ordered to submit a business improvement plan to the ministry within a month.
Acknowledging low morale, employees said they hesitated to report because they were concerned that extra checks would be a burden on doctors, according to the ministry.
Novartis Pharma has also been found to have failed to report some 10,000 other cases of side effects. The ministry ordered the drugmaker to report on its own investigation into these cases by the end of August.
A Novartis Pharma official said the company will take seriously the action taken by the ministry and make efforts to regain trust by implementing measures to prevent the recurrence of similar incidents.