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November 12,  2003

FDA Statement on Reported Health Problems With Remedia-Brand Kosher Soy-Based Infant Formula


(SafetyAlerts) FDA is aware of reports by Israeli health officials that infants may have been injured by the use of Remedia soy-based infant formula -- a product reportedly made in Germany and exported to Israel. The preliminary report issued by the Israeli Ministry of Health states that the Remedia soy-based formula was deficient in the essential vitamin thiamine. Thiamine deficiency results in a condition known as beri-beri which can result in a variety of cardiac and neurological problems, and, if untreated, death.

FDA has determined that no commercial entries were distributed in the United States. It is possible that non-commercial quantities of the product have been brought in by travelers or through the mails.

FDA is working with other health agencies such as the City of New York Department of Health and Mental Hygiene to look into this matter. Anyone who may have Remedia soy-based formula should not use the product and contact their pediatrician as well as the local U.S. Food and Drug Administration office or the agency?s Emergency Operations number, 301-443-1240. FDA will collect the product for testing in our laboratories.

FDA would like the public to be aware of the following information issued by the Israeli Ministry of Health:

Preliminary report - An outbreak of beriberi in Israel due to a lack of thiamine in a soy-based infant formula. November 8, 2003.

On Thursday, November 6, a cluster of four cases of encephalopathy in infants aged 2 months to 9 months hospitalized in the PEDIATRIC INTENSIVE CARE UNIT PCIUin Schneider's Children Hospital in Israel, were reported to the Ministry of Health. The clinical signs reported by the parents were: constipation, agitation, apathy, vomiting, lack of appetite, and later on, diarrhea, grunting, nystagmus, convulsions and unconsciousness.

An investigation by the public health authorities revealed that the one common denominator was that all were fed, almost exclusively, a soy-based infant formula "Remedia Soy Formula", produced by Humana (Germany) and imported to Israel by the company Remedia. A subsequent investigation yielded a further three cases, all being fed the same soy-based formula. The soy-based infant formula was taken to the Public Health laboratories for examination for infectious agents, toxins, heavy metals and thiamine levels. On Friday, November 8, the Ministry of Health issued an alert to the public, advising them to immediately cease using this specific formula. The cans were removed from the shelves in all stores and all sales of the product were halted. Following this alert, more cases were reported including three infants who died two to three weeks ago, two of them with cardiomyopathy.

The working hypothesis at this time was beriberi, due to a lack of thiamine in the diet.

On Sunday, November 8, the results of laboratory tests confirmed that the Remedia soy based formula did not contain any thiamine. The Ministry of Health has advised parents of all infants who had been fed this formula during the last two months, to report to their pediatricians to receive a prescription for two weeks of thiamine supplementation.

To date, 17 cases, including three deaths, have been reported.

Dorit Nitzan Kaluski MD, MPH, RD - Director, Food and Nutrition Administration, Israel Ministry of Health.

Manfred S Green MD, PhD - Director, Israel Center for Disease Control

Source: FDA

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