02 September 2014 | News | By BioSpectrum Bureau
This expose has added to the string of scandals that the company is already facing in the country
Singapore: Landing in trouble again, the Japanese arm of the Swiss drug maker Novartis has now admitted that it concealed facts related to side effects in its leukaemia patients. The company admitted that it did not report more than 2,500 cases of serious side effects in patients using its leukaemia and other cancer drugs. The cases, the company said reportedly included some fatalities too.
Ahead of the local Japanese authorities instructing the Novartis subsidiary to clean up its operations, this expose has added to the string of scandals that the company is already facing in the country.
In an official statement issued by Novartis, the company revealed that it had failed to report at least 2,579 cases where patients had suffered serious potential side effects from its drugs to the regulators. Further, news reports by Japan's Jiji Press news agency added that they included some fatal cases too.
As the statement was released, it caused more ripples in the Japanese media that soon claimed that with the company probing 6,000 more cases, the number of unreported cases could rise further.
This issue has also heightened the problems for Novartis in Japan that had recently replaced its top executives over allegations that it did not properly disclose the possible side effects of its leukaemia treatments. Two months back, Japanese prosecutors had also laid charges against the unit over claims that falsified data was used to exaggerate the benefits of a popular blood-pressure drug. It was reported then that prosecutors also indicted a former employee, Mr Nobuo Shirahashi, alleging that he manipulated data in clinical studies that were later used in marketing the drug Valsartan.