MS Drug May Come with Increased Risk of Heart Issues, FDA Says

MS Drug May Come with Increased Risk of Heart Issues, FDA SaysGilenya, a drug used to treat multiple sclerosis (MS), should not be used to treat patients with specific pre-existing or recent heart conditions or stroke, and should not be given to those who have been taking medications to correct arrhythmia, the U.S. Food and Drug Administration announced on Monday.

According to HealthDay, FDA made the ruling after evaluating a report of a patient who died within one day of being given Gilenya for the treatment of MS. Government health officials also analyzed other clinical trials and data on the drug since it had been approved, including reports of patients who died from cardiovascular causes or by an unknown occurrence.

Although the potentially dangerous drug has not yet been directly linked to the heart-related deaths, the agency said the cardiovascular effects of the drug after the first dose should be further studied. The researchers' analysis indicated that the maximum heart rate-lowering effect of the medication comes within six hours of taking the drug, however the effect has shown to appear as late as 20 hours after the patient takes the first dose of the drug.

The FDA announced that all patients being treated with Gilenya should be regularly monitored by health officials for at least six hours after the first dose, with pulse and blood pressure measurements taken every hour.

If patients taking Gilenya begin to develop dizziness, tiredness, irregular heartbeat or palpitations, they should seek immediate medical attention and stop taking the drug until they can speak with their doctor, the FDA recommended.

According to the National Multiple Sclerosis Society, there are a number of FDA-approved disease-modifying drugs that can be used to treat MS, which reduce the activity of the disease in the body.