The safety of Novartis’ multiple sclerosis drug Gilenya is under investigation after a patient in the US died after taking the treatment for the first time.
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The 59-year-old man began taking the medicine on 22 November 2011 and was monitored for six hours after his first dose, but died the next day.
Novartis said in a statement that the exact cause of death has not been established and the role of Gilenya "can neither be confirmed nor excluded at this time."
Gilenya (fingolimod) is the first pill approved by the US Food and Drug Administration for the treatment of multiple sclerosis.
Since the approval, more than 28,000 patients have received the pill to date and no deaths have occurred until now.
In a research note, Sanford Bernste analyst Jack Scannell said the sudden death "smacks of being cardiovascular in nature", arguing that the possibility of a temporary slowdown in heart rate after patients start treatment with Gilenya is one of the reasons why it is recommended that patients be monitored in a doctor’s office after treatment begins.
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By GlobalDataNovartis has submitted details of the case to regulators and said that it "takes patient safety very seriously and we are currently gathering all available details on this case".
Caption: Novartis cannot confirm or exclude the role of Gilenya in the dealth of an an MS sufferer.
