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.