History
Three unusual cases of children presenting with symptoms similar to Bartter syndrome were reported to the CDC in mid 1979. The infants were less than 10 months of age, all had a hypochloremic, hypokalemic alkalosis and were failing to thrive.
To investigate, the CDC sent a survey to a sample of pediatric nephrologists (including Stanley Hellerstein, MD, retired CMH nephrologist) to report on their experience with hypochloremic, hypokalemic alkalosis diagnosed since January 1, 1979. Thirty-one cases were identified. The cohort included males and females, all were less than 10 months of age. (MMWR Report (1996)).
Diet histories were obtained for 27 of the infants. All but one infant was being fed a formula called Neo-Mull-Soy manufactured by Syntex of Palo Alto California. The company stopped formula production, formula delivery, asked people in the supply chain to pull formula from the shelf and stop sales and notified pediatricians. Although not all retailers complied with the recall. (The Free Lane Star, Fredericksburg, Va, 1980, Sept 10.)
To decrease the sodium in the final product, salt was removed from the processing. When salt was removed, chloride was removed as well as sodium. It was determined that the low chloride formula was the source of the alkalosis.
Prior to this event formula was regulated under 21 CFR 105.65, Infant Foods, specified levels for macro-nutrients, and some micro-nutrients. The regulation prior to 1980 did not:
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To investigate, the CDC sent a survey to a sample of pediatric nephrologists (including Stanley Hellerstein, MD, retired CMH nephrologist) to report on their experience with hypochloremic, hypokalemic alkalosis diagnosed since January 1, 1979. Thirty-one cases were identified. The cohort included males and females, all were less than 10 months of age. (MMWR Report (1996)).
Diet histories were obtained for 27 of the infants. All but one infant was being fed a formula called Neo-Mull-Soy manufactured by Syntex of Palo Alto California. The company stopped formula production, formula delivery, asked people in the supply chain to pull formula from the shelf and stop sales and notified pediatricians. Although not all retailers complied with the recall. (The Free Lane Star, Fredericksburg, Va, 1980, Sept 10.)
To decrease the sodium in the final product, salt was removed from the processing. When salt was removed, chloride was removed as well as sodium. It was determined that the low chloride formula was the source of the alkalosis.
Prior to this event formula was regulated under 21 CFR 105.65, Infant Foods, specified levels for macro-nutrients, and some micro-nutrients. The regulation prior to 1980 did not:
- mandate reporting of changes in infant formula production
- process of formula recalls
- records management requirements
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