According to the FDA:
“Aluminum may reach toxic levels with prolonged parenteral administration [this means injected into the body] if kidney function is impaired . . . Research indicates that patients with impaired kidney function, including premature neonates [babies], who received parenteral levels of aluminum at greater than 4 to 5 micrograms per kilogram of body weight per day, accumulate aluminum at levels associated with central nervous system and bone toxicity [for a tiny newborn, this toxic dose would be 10 to 20 micrograms, and for an adult it would be about 350 micrograms]. Tissue loading may occur at even lower rates of administration.” [Department of Health and Human Services, Food and Drug Administration, Document NDA 19-626/S-019, Federal Food, Drug and Cosmetic Act for Dextrose Injections.]
And also:
“Aluminum content in parenteral drug products could result in a toxic accumulation of aluminum in individuals receiving TPN therapy. Research indicates that neonates [newborns] and patient populations with impaired kidney function may be at high risk of exposure to unsafe amounts of aluminum. Studies show that aluminum may accumulate in the bone, urine, and plasma of infants receiving TPN. Many drug products used in parenteral therapy [injections] may contain levels of aluminum sufficiently high to cause clinical manifestations [symptoms] . . . parenteral aluminum bypasses the protective mechanism of the GI tract and aluminum circulates and is deposited in human tissues. Aluminum toxicity is difficult to identify in infants because few reliable techniques are available to evaluate bone metabolism in . . . infants . . . Although aluminum toxicity is not commonly detected clinically, it can be serious in selected patient populations, such as neonates [newborns], and may be more common than is recognized.” [Department of Health and Human Services, Food and Drug Administration, Document 02N-0496, Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition. Available online at: http://www.fda.gov/ohrms/dockets/98fr/oc0367.pdf]
So basically from those documents we learn that if a premature baby receives more than 10 mcg of aluminum in an IV, it can accumulate in their bones and brain, and can be toxic.
The FDA maximum requirements for aluminum received in an IV is 25 mcg per day. The suggested aluminum per kg of weight to give to a person is up to 5mcg. (so a 5 pounds baby should get no more than 11mcg of aluminum.) Anything that has more than 25 mcg of aluminum is *supposed* to have a label that says:
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 [micro]g/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. [http://www.accessdata.fda.gov/.../cfcfr/CFRSearch.cfm...]
“Aluminum may reach toxic levels with prolonged parenteral administration [this means injected into the body] if kidney function is impaired . . . Research indicates that patients with impaired kidney function, including premature neonates [babies], who received parenteral levels of aluminum at greater than 4 to 5 micrograms per kilogram of body weight per day, accumulate aluminum at levels associated with central nervous system and bone toxicity [for a tiny newborn, this toxic dose would be 10 to 20 micrograms, and for an adult it would be about 350 micrograms]. Tissue loading may occur at even lower rates of administration.” [Department of Health and Human Services, Food and Drug Administration, Document NDA 19-626/S-019, Federal Food, Drug and Cosmetic Act for Dextrose Injections.]
And also:
“Aluminum content in parenteral drug products could result in a toxic accumulation of aluminum in individuals receiving TPN therapy. Research indicates that neonates [newborns] and patient populations with impaired kidney function may be at high risk of exposure to unsafe amounts of aluminum. Studies show that aluminum may accumulate in the bone, urine, and plasma of infants receiving TPN. Many drug products used in parenteral therapy [injections] may contain levels of aluminum sufficiently high to cause clinical manifestations [symptoms] . . . parenteral aluminum bypasses the protective mechanism of the GI tract and aluminum circulates and is deposited in human tissues. Aluminum toxicity is difficult to identify in infants because few reliable techniques are available to evaluate bone metabolism in . . . infants . . . Although aluminum toxicity is not commonly detected clinically, it can be serious in selected patient populations, such as neonates [newborns], and may be more common than is recognized.” [Department of Health and Human Services, Food and Drug Administration, Document 02N-0496, Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition. Available online at: http://www.fda.gov/ohrms/dockets/98fr/oc0367.pdf]
So basically from those documents we learn that if a premature baby receives more than 10 mcg of aluminum in an IV, it can accumulate in their bones and brain, and can be toxic.
The FDA maximum requirements for aluminum received in an IV is 25 mcg per day. The suggested aluminum per kg of weight to give to a person is up to 5mcg. (so a 5 pounds baby should get no more than 11mcg of aluminum.) Anything that has more than 25 mcg of aluminum is *supposed* to have a label that says:
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 [micro]g/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. [http://www.accessdata.fda.gov/.../cfcfr/CFRSearch.cfm...]
