Israeli-made blood therapy Omrigam is to be restricted to use under strict supervision, or replaced, because a production flaw is feared to increase the risk of excessive blood clotting, the Health Ministry announced yesterday.
The fault reduces Omrigam's safety and could be related to patients' deaths.
The malfunction was found in the therapy's production line after a patient treated with Omrigam died. After probing the incident, the Health Ministry found about 10 cases in which patients treated with it had suffered from excessive clotting. Two of them died.
The ministry fears the flaw increases the risk of developing blood clots and pulmonary embolism - a blood clot blocking one of the arteries to the lungs, which could cause death. The ministry stresses, however, that "the cause for the patients' death is unclear and could stem from their serious illness or a side effect of the medicine."
Omrigam, produced by Omrix Biopharmaceuticals, consists of immunoglobulins - antibodies produced from plasma derived from blood units collected by Magen David Adom for use in Israel and from plasma imported from the United States.
The immunoglobulins are a medicine given in transfusion as treatment for immune system failure. Ayelet Shenar, head of MDA's blood services, says "this is customary treatment for autoimmune diseases, in which the immune system attacks itself."
Patients with no immune system need immunoglobulins in a continuous transfusion. These include 'bubble boys' born with a genetic deficiency (SCID ) linked to the X chromosome. It is also administered to patients suffering from autoimmune diseases including lupus and blood vessel infections.
"Recently they have been used to treat partial immune system failure, such as joint diseases," Shenar said.
Excessive clotting is a known side effect of immunoglobulins. "The preparation has a high manifestation of excessive clotting in about 3-4 percent of the patients," a Health Ministry official said.
A similar case in September led the American Octapharma company to take Octagam off the shelves. Octagam contains immunoglobulins, which were found to raise the risk of excessive clotting and possibly lead to death, via cardiac events or a stroke.
The ministry is examining alternative treatments to Omrigam and will administer the product only under close supervision.
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