Tuesday, January 24, 2012

Drug giant Novartis under investigation following patient deaths

The pharmaceutical company Novartis is under investigation by the European Union following the deaths of 11 patients who took the drug Gilenya.

Novartis AG, the Swiss manufacturer of the multiple sclerosis drug, is subjected to a European wide investigation after at least 11 patients taking the medicine died (as announced by several media outlets and by the Multiple Schlerosis Resource Center). The drug which was taken goes under the brand name Gilenya. The drug is relatively new and was only licensed last year in the European Union (the drug was approved for use in the USA in 2010).

The deaths of the patients have led regulators to be concerned that Gilenya may trigger heart problems, especially after patients have taken their first dose. One patient reportedly died within 24 hours of taking the drug. In November 2011, a patient died in the USA in an event that may have been related to the drug or for other reasons. This remains the subject of an FDA investigation.

The investigation into the ill-health effects and into Novartis is being undertaken by the European Medicines Agency (EMA), which has similar status to the U.S. Food and Drug Administration (FDA). The EMA is expected to conclude its investigation in March. In addition to the European concerns, Fox News have reported that the FDA are also conducting their own data analysis and will make an announcement about the use of Gilenya in the near future.

Posted via email from Jack's posterous

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