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Novartis Japan Hit With 15-day Suspension for Failing to Report Drug Side Effects

by Dr. Trupti Shirole on March 1, 2015 at 5:14 AM
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 Novartis Japan Hit With 15-day Suspension for Failing to Report Drug Side Effects

The Japanese unit of Swiss pharmaceutical giant Novartis has been ordered to temporarily suspend its operations for failing to report drug side effects, revealed the health ministry. This is reportedly a first for a pharmaceutical firm operating in Japan. During the 15-day suspension, which is to start from March 5, the company will not be able to sell most of its drugs.

Drug-makers are required to report serious side effects of any drugs to the ministry within 15 to 30 days. In July 2014, Tokyo-based Novartis Pharma K.K., was handed a business improvement order for failing to properly report side effects of two leukaemia drugs. Also, the prosecutors laid charges against the unit over claims that falsified data were used to exaggerate the benefits of a popular blood-pressure drug. They also indicted a former employee, Nobuo Shirahashi, alleging he manipulated the data in clinical studies that were later used in marketing the drug Diovan (Valsartan).

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In December 2014, Novartis admitted to have failed to promptly report more than 3,000 cases of adverse effects from about two dozen company drugs.

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