FDA places restrictions on oral MS drug
Patients on Gilenya for MS May Require Extended Monitoring
HealthDay News -- Based on the report of a patient who died after taking one dose of the multiple sclerosis (MS) drug fingolimod (Gilenya, Novartis) and on clinical trial data, the FDA has issued a Drug Safety Communication recommending extended monitoring for certain patients taking this drug.
Although a cause of death was not identified, the patient in question, who also had extensive brainstem MS lesions, died within 24 hours of taking the drug. This prompted the agency to re-evaluate clinical trial data on the effects of fingolimod on heart rate and BP.
The FDA is now advising against prescribing fingolimod in patients who have experienced a major cardiovascular event in the past six months, including MI, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, class III/IV heart failure, or those who are taking class Ia or III antiarrhythmic drugs.
All patients started on fingolimod should have pulse and BP measurements taken every hour for the first six hours after medication initiation, and electrocardiogram testing should be performed prior to dosing and at the end of the observation period, the agency recommends. Cardiovascular monitoring should continue until any symptoms resolve.
The agency noted that fingolimod usually lowers a patient's heart rate within six hours of the first dose, but this effect can occur up to 12 to 20 hours after the first dose. Based on these findings, the FDA suggests monitoring patient heart rates longer than six hours in certain high risk patients who experience a heart rate below 45 beats per minute, as well as those:
- Who develop severe bradycardia after administration of the first dose of fingolimod
- With certain pre-existing conditions in whom bradycardia may be poorly tolerated
- Receiving therapy with other drugs that slow the heart rate or atrioventricular conduction
- With QT interval prolongation prior to starting fingolimod, or at any time during the cardiovascular monitoring period
- Receiving therapy with other drugs that prolong the QT interval and that can cause a serious and life-threatening abnormal heart rhythm called Torsades de pointes
"Extended monitoring should include continuous ECG monitoring that continues overnight," the agency said.
The FDA maintains that the treatment benefits of fingolimod outweigh its potential risks when the medication is used as described on the updated drug label, but is encouraging patients to contact their health-care provider if they experience dizziness, tiredness, palpitations or irregular heart beat while taking fingolimod