October 3, 2014 — The blockbuster multiple sclerosis (MS) drug Gilenya has been linked to thousands of adverse events reports, raising serious safety concerns about its fast-track approval by the FDA.
The Institute for Safety Medication Practices (ISMP) published a QuarterWatch report linking Gilenya with 2,716 adverse events during a one-year period.
According to investigators, this data shows that “fingolimod remains a high-risk drug with multiple toxicities.” They estimated that serious injuries were reported at a rate of approximately 17% per patient-year of exposure.
The ISMP warned:
“We identified 473 cases of heart rhythm disturbance, primarily bradycardia and heart block. They include 13 patient deaths, 11 cases classified as life-threatening and 141 resulting in hospitalization. Also identified was a large group of cases (n = 348) indicating macular degeneration or less specific adverse effects on the eye.”
This is not the first time Gilenya has been linked to serious safety concerns. Last year, the U.S. Food and Drug Administration (FDA) published a warning about brain infections. In 2012, the FDA recommended monitoring patients for six hours after their first dose due to the risk of deadly heart rhythm disturbances.
Before Gilenya was approved in 2010, clinical trials indicated a possible risk toxicity, infection, reduced pulmonary function, birth defects, macular edema, and more. Even so, the FDA fast-tracked approval without requiring rigorous safety studies because there were no other drugs on the market for people with MS.
Last month, Novartis presented encouraging data from two clinical studies. These studies suggested that Gilenya was effective at stabilizing brain-shrinkage — patients with MS had similar rates of brain-shrinkage as people without MS. In the first half of 2014, Gilenya generated $1.1 billion in sales, up 30% from last year.