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Remedia suspected in 10 babies' encephalopathy
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Judy Siegel-Itzkovich Nov. 9, 2003
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The common denominator so far among 10 babies hospitalized with encephalopathy in several months, three in the past week, is that all of them drank non-dairy soya-based Remedia infant formula. Four of them are in serious condition at Schneider Children's Medical Center of Israel in Petah Tikva. Two of the 10 babies have died.
Dr. Dorit Nitzan-Kalusky, head of the Health Ministry's Food and Nutrition Service, decided over the weekend to take this type of formula off the shelves at least until lab tests determine if there was anything in the German-made powder that could have caused the babies to suffer convulsions and go into a coma. Thousands of babies consume the formula.
The powder is imported by the Israeli company from Germany, which makes it without any cow's milk components for children who suffer from lactose intolerance or whose Haredi parents prefer a non-dairy formula so as no to complicate meat meals.
The Health Ministry said Saturday night that the German company changed the components of its formula last spring, which is when the complications began to appear. The ministry also said that because of the relatively widespread use of the non-dairy formula in the haredi community, rabbis permitted loudspeakers to be used in their neighborhoods on Shabbat to warn parents against using the formula. Announcements about the formula were also made in synagogues. Clalit Health Services reported that over 10,000 calls were received from worried parents whose babies drink the formula, and hundreds of babies who seemed sick were brought to emergency rooms.
The symptoms of the condition leading to encephalopathy include apathy, nausea, vomiting, and later convulsions and loss of consciousness.
Schneider pediatricians reported that they were surprised by the three cases in one week, as they usually treat one case of encephalopathy – which can have numerous causes – in two months. Suspicious, they immediately informed the Health Ministry, which began interviewing the families for in-depth epidemiological investigation. The babies had not been in any contact, but all of them had been fed the non-dairy Remedia formula. While it has not been proven that the formula had something that caused the illness, the company was informed and told that the product would temporarily be taken off the market.
Dr. Itamar Shalit, head of the infectious diseases unit at Schneider, said there has so far been no sign so far of any virus, bacteria, or other infectious agent in the babies and that it was not contagious, as no one in the families had been infected. "This is a very rare, enigmatic occurrence," he said. "It is not clear whether the babies have suffered any permanent brain damage, but the brain stem in the brain has been affected, according to magnetic resonance instrument scans. Still, it may be reversible. One child who reached Schneider a few months ago suffered brain damage and is still hospitalized, while another recovered completely."
Shalit said that epidemiological studies and tests would look for some toxic or environmental cause in addition to an infectious agent. The four babies are attached to a respirator and receiving antibiotics and antiviral drugs at least until a pathogen is ruled out.
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Judy Siegel-Itzkovich Nov. 9, 2003
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The common denominator so far among 10 babies hospitalized with encephalopathy in several months, three in the past week, is that all of them drank non-dairy soya-based Remedia infant formula. Four of them are in serious condition at Schneider Children's Medical Center of Israel in Petah Tikva. Two of the 10 babies have died.
Dr. Dorit Nitzan-Kalusky, head of the Health Ministry's Food and Nutrition Service, decided over the weekend to take this type of formula off the shelves at least until lab tests determine if there was anything in the German-made powder that could have caused the babies to suffer convulsions and go into a coma. Thousands of babies consume the formula.
The powder is imported by the Israeli company from Germany, which makes it without any cow's milk components for children who suffer from lactose intolerance or whose Haredi parents prefer a non-dairy formula so as no to complicate meat meals.
The Health Ministry said Saturday night that the German company changed the components of its formula last spring, which is when the complications began to appear. The ministry also said that because of the relatively widespread use of the non-dairy formula in the haredi community, rabbis permitted loudspeakers to be used in their neighborhoods on Shabbat to warn parents against using the formula. Announcements about the formula were also made in synagogues. Clalit Health Services reported that over 10,000 calls were received from worried parents whose babies drink the formula, and hundreds of babies who seemed sick were brought to emergency rooms.
The symptoms of the condition leading to encephalopathy include apathy, nausea, vomiting, and later convulsions and loss of consciousness.
Schneider pediatricians reported that they were surprised by the three cases in one week, as they usually treat one case of encephalopathy – which can have numerous causes – in two months. Suspicious, they immediately informed the Health Ministry, which began interviewing the families for in-depth epidemiological investigation. The babies had not been in any contact, but all of them had been fed the non-dairy Remedia formula. While it has not been proven that the formula had something that caused the illness, the company was informed and told that the product would temporarily be taken off the market.
Dr. Itamar Shalit, head of the infectious diseases unit at Schneider, said there has so far been no sign so far of any virus, bacteria, or other infectious agent in the babies and that it was not contagious, as no one in the families had been infected. "This is a very rare, enigmatic occurrence," he said. "It is not clear whether the babies have suffered any permanent brain damage, but the brain stem in the brain has been affected, according to magnetic resonance instrument scans. Still, it may be reversible. One child who reached Schneider a few months ago suffered brain damage and is still hospitalized, while another recovered completely."
Shalit said that epidemiological studies and tests would look for some toxic or environmental cause in addition to an infectious agent. The four babies are attached to a respirator and receiving antibiotics and antiviral drugs at least until a pathogen is ruled out.
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