Novartis says it failed to reveal 10,000 reports of side effects. The Wall Street Journal reports that the drugmaker says it has identified at least 10,000 cases which may never have been reported and which span a variety of drugs, including Gleevec, Tasigna, Exelon and Xolair.
Novartis tells the WSJ it has passed along this information to the Japanese Ministry of Health Labor and Welfare and the FDA, among others.
Novartis has been working against a series of bad PR moments, and this latest one compounds a problem highlighted two months ago, when Novartis said it had shredded or deleted some safety reports surrounding leukemia medications Gleevec and Tasigna.
