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Investigation Underway into Death of Gilenya Patient

12/12/2011

Novartis has confirmed that a person with MS died one day after taking the first dose of Gilenya; however, the exact cause of death has not been determined and it is too soon to know whether Gilenya played a role in the person’s death, representatives from the drug company said.

The death occurred on Nov. 23rd. and it is the first reported within 24 hours of the first Gilenya dose in more than 28,000 people who have taken the drug, according to Novartis. After taking the initial dose of Gilenya on Nov. 22nd, the patient was monitored for the next six hours, as is recommended by the U.S. Food and Drug Administration (FDA), Novartis reported.

Novartis said it has sent details of the case to the FDA and other regulatory authorities. Gilenya, the first oral pill for MS, was approved in the U.S. last year. The general information line for Novartis customers is 888-NOW-NOVA (669-6682).



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