April 20, 2012 -- Novartis, the maker of the drug Gilenya (fingolimod), a once-daily oral capsule taken for multiple sclerosis, has added stronger warnings to labels and prescription information about the drug's possible heart risks, according to a company statement.
Labels will now recommend that all patients have an electrocardiogram (ECG) before taking their first dose of the MS drug. In addition, those starting treatment with Gilenya are also advised to get a second ECG six hours after their first dose of the medication.
New patients are advised to take the drug for the first time in their doctor's office with hourly blood pressure and heart rate checks during a six-hour monitoring period.
The revised label information will not affect people currently taking the drug. But it may apply to them if they stop taking Gilenya for more than two weeks and need to restart the treatment. They would need to repeat the ECGs as well as the six-hour monitoring period.
These changes follow an FDA report in December 2011 of an MS patient who died within 24 hours of taking the first dose of Gilenya. The agency is still looking into whether the drug was responsible for the patient's death.
The drug is known to slow heart rate, especially in the first 30 days of its use. It may also leave some people feeling dizzy or tired, or they may feel heart palpitations or chest pain that usually improves within the first 24 hours of treatment.
In the U.S., labels will also recommend that people with certain heart conditions or those taking certain medications for these heart problems would need to be monitored overnight by a health professional after taking their first dose of this MS drug.
According to the National Multiple Sclerosis Society, about 400,000 Americans have MS. The autoimmune disease affects the brain and spinal cord, which can result in weakness in one or more limbs, balance problems, and numbness.
Risks vs. Benefits
Gilenya is taken once a day by mouth to reduce the number of MS flares in people with relapsing types of MS. It was approved for use by the FDA in September 2010.
It's the first MS treatment to be taken orally; other medications for this condition are given by injection.
The drug is also known to lower the number of white blood cells in the blood, so another possible side effect of Gilenya is an increased risk of serious infection. It may also cause vision, breathing, or liver problems in some people.
Recently, the Institute for Safe Medication Practices, a nonprofit watchdog group, has urged the FDA to put more restrictions on the use of Gilenya. The group reviewed the number of side effects of the drug reported to the FDA MedWatch program in the second quarter of 2011, and it concluded that "the FDA and manufacturer should consider substantial restrictions on its use and enhanced monitoring."
The drug's manufacturer, while adding new restrictions to its label, still stresses its value for patients with relapsing types of MS.
"Gilenya represents an important treatment option for relapsing forms of MS," says Barry Singer, MD, director of the MS Center for Innovations in Care at Missouri Baptist Medical Center, in a statement. "Choosing appropriate patients for Gilenya therapy and patient safety is essential."