October 3, 2014 — Thousands of adverse events have been linked to Gilenya , a multiple-sclerosis drug, raising concerns about whether the medication was approved too quickly.

In the latest QuarterWatch report from the Institute for Safe Medication Practices (ISMP), at least 2,716 adverse events were reported within one year, “showing that fingolimod remains a high-risk drug with multiple toxicities.”

Some of the most serious adverse events included:

  • 473 cases of heart rhythm disturbances (mostly bradycardia and heart block)
  • 13 patient deaths
  • 11 life-threatening injuries
  • 141 injuries resulting in hospitalization
  • 348 cases of macular degeneration or less specific side effects in the eye
  • 172 cases of viral infections

Gilenya is the first immunosuppressant drug for the treatment of multiple sclerosis (MS). It works by inhibiting lymphocytes from exiting the lymph nodes, which can result in a significant decrease in white blood cells. Since its approval in 2010, Ii has proven to be a blockbuster for Novartis. Sales were $1.1 billion in the first half of 2014, up 30% from last year.

Last month, Novartis presented encouraging data from two clinical trials indicating that MS patients treated with Gilenya had stable rates of brain shrinkage during a six-year period — similar to the rate in patients without MS.

Even so, serious safety concerns remain. In 2012, the FDA warned that Gilenya could disrupt normal heart rhythm and recommended monitoring patients for six hours after the first dose. Last year, the FDA warned about a possible risk of brain infections.

Clinical studies have also found evidence of liver toxicity, infection, reduced pulmonary function, birth defects, macular edema, and potentially an increased risk of cancer. Despite these risks, the FDA fast-tracked approval of Gilenya with minimal testing because there were no other drugs for MS on the market at that time.


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