FDA completes safety review of MS drug

May 25, 2012

The multiple sclerosis drug fingolimod (Gilenya, Novartis) is now contraindicated for use in patients with certain pre-existing or recent heart conditions or stroke, or who are taking certain antiarrhythmic medications, according to FDA

The multiple sclerosis (MS) drug fingolimod (Gilenya, Novartis) is now contraindicated for use by patients with certain pre-existing or recent heart conditions or stroke, or who are taking certain antiarrhythmic medications, according to FDA.

However, after completing its safety review, FDA concluded that fingolimod’s contribution to the deaths in MS patients taking the oral medication was unclear and that the number of deaths did not appear to be higher in patients treated with fingolimod compared with patients who were not treated with it.

“Patients should not stop taking Gilenya without talking to their healthcare professional,” FDA said in a news release. “They should contact their healthcare professional and seek immediate care if they develop dizziness, tiredness, irregular heartbeat, or palpitations--signs of a slowing heart rate.”

FDA said it “continues to believe that the benefits of treatment with Gilenya outweigh its potential risks when it is used as described in the updated drug label.”

The review was initiated after a patient died with 24 hours of taking the first dose of fingolimod.

FDA also included a re-evaluation of clinical trial data regarding the drug’s effects on heart rate and blood pressure.

The bradycardic effects of fingolimod have been confirmed to be biphasic (within 6 hours and between 12 and 20 hours after the dose). As a result, FDA suggested monitoring a patient’s heart rate beyond the originally recommended 6 hours in patients with a heart rate of 45 beats per minute or lower within the first 6 hours after a dose, or in patients whose lowest heart rate has been within the first 6 hours.

Extended monitoring was also recommended in patients with QT prolongation and in patients who are already taking medication that slows heart rate or atrioventricular conduction. Extended monitoring should include continuous ECG monitoring through the night.