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