A recent notice from Health Canada and Pharmaceutical Partners of Canada Inc. (PPC) stated that PPC brand Calcium Gluconate Injection 10% has been found to contain aluminum. The Warning section of the package insert states: “This product contains aluminum that might be toxic. Aluminum might reach toxic levels with prolonged administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and because 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 μg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.” To address the issue of aluminum toxicity, PPC is investigating alternate processes and alternate container materials, such as plastic vials, to determine if they will reduce the amount of aluminum present in the product and if they are suitable for utilization. PPC will inform healthcare professionals of the date at which the newly manufactured vials are expected to be available. Any cases of serious or unexpected adverse reactions in patients receiving Calcium Gluconate Injection 10% should be reported to PPI or Health Canada.
