Novartis Pharma fails to report over 2,500 serious side effects from its drugs

JIJI

Novartis Pharma K.K. said it has failed to report at least 2,579 cases of serious side effects to the health ministry, including one that was fatal, related to its drugs for leukemia and other diseases, although employees were aware of the problems.

Of the total, 1,313 cases were related to Glivec and 514 to Tasigna, both drugs for leukemia treatment. Another 261 cases involved Afinitor, a cancer drug, the Japanese unit Swiss drug giant Novartis AG said Friday.

The findings were reported to the Health, Labor and Welfare Ministry the same day.

The marketing staff at Novartis Pharma recognized the side effects but failed to report them to the division in charge, breaking the drug firm’s internal rules, Novartis Pharma said. They were not fully aware of the importance of the problem and higher-ranking officials failed to supervise them properly, it said.

In addition to the confirmed cases, there are 6,118 more suspected cases of side effects, Novartis Pharma said, adding that it is still examining them.

An investigation the company launched in April that covered all employees found that about 10,000 cases of side effects were not reported to the internal division in charge, during and after 2002.

The health ministry on July 31 ordered the company to conduct another probe and report the results by the end of August.

The ministry also issued a business improvement order to Novartis Pharma the same day for its failure to report 21 separate cases of serious side effects involving Glivec and Tasigna.

On Friday, Novartis Pharma submitted a set of corrective measures, including for employee training, to the ministry.