14 May 2014, BioSpectrum Bureau , BioSpectrum
Singapore: Swiss giant Novartis Pharma's Japanese arm has prompted the Japanese health ministry to launch an investigation under possible violation of the pharmaceutical affairs law. It has been found to have failed to inform authorities about serious side-effects of its leukemia drug, Tasigna.
The revelation came from a survey conducted by the drug company on pharmacists and doctors between April 2013 and January 2014. Novartis collected information on 3,000 Japanese patients who were taking the drug last year, and found 30 cases of side effects out of which 10 should have been reported to the government.
The health ministry is expected to consider taking regulatory measures against Novartis, such as an order to suspend operations and a business improvement order, if it is found to have violated the pharmaceutical affairs law.
Novartis is facing trouble for quite a while now in Japan, with its blood pressure drug Diovan as well as for using misleading data to promote its drug.