FDAnews Drug Daily Bulletin

Pharma Blog Watch

Dec. 13, 2011
Gilenya: Novartis Probes Possible Death (Pharmalot Blog)
A year after Novartis won FDA approval for its multiple sclerosis (MS) drug, Gilenya (fingolimod), reports of a possible death have been disclosed and the company is looking for answers, blogger Ed Silverman writes. “Specifically, this is the first death of a patient within 24 hours of taking a first dose,” Silverman writes. “The case becomes the first involving sudden death among some 28,000 patients who have taken the drug. So far, the drugmaker has not issued a so-called ‘Dear Doctor’ letter to alert physicians to the death,” he adds. Analysts have predicted Gilenya could reach blockbuster status. “The disclosure has the potential to cast a pall over the drug,” Silverman writes.