Ministry endorses European warning on MS drug

Health Ministry adopts recommendations of European Medicines Agency on use of Gilenya (fingolimod).

January 22, 2012 22:58
1 minute read.
Drug company

Pharmacist pouring something 311. (photo credit: NATI SHOHAT/FLASH90)


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The Health Ministry decided on Sunday to adopt the recommendations of the European Medicines Agency (EMA) regarding the use of Gilenya (fingolimod), a drug for treating the neurological autoimmune disease multiple sclerosis.

EMA is investigating a number of deaths that occurred not long after patients with relapsingremitting MS took the oral drug. The drug was added to Israel’s basket of medical technologies only a few weeks ago.

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The oral medication, developed and marketed by Novartis pharmaceuticals, competes with all other MS medications, including the Israeli-developed Copaxone and Rebif, which are injected by the patient on a daily basis. Gilenya, which was found to reduce the frequency and extent of neurological attacks, is a phospholipid, which captures lymphocytes in lymph nodes, thus preventing them from joining autoimmune attacks on nervous system.

The ministry in Jerusalem said there was one reported death in the United States of an MS patient who was taking fingolimod. There were also six other unexplained heart attacks deaths suspected of being connected to taking the oral drug.

Israeli doctors who have prescribed the drug have been advised to tell their MS patients who take Gilenya to report any side effects. The Health Ministry’s medical administration said that before patients start taking the drug they should undergo an electrocardiogram (EKG). After taking the pill for the first time, the patient should be watched via EKG for six hours. Blood pressure and pulse should be taken hourly six times after the first pill is swallowed.

If the patient suffers from brachycardia or other heart symptoms, the time the patient is directly observed could be extended, the ministry said. MS patients who have been prescribed Gilenya should report to the doctor immediately any heart problems such as chest pains, weakness or dizziness.

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